Lower risk Medical device recall · FDA · Published July 18, 2017
Roche cobas 6000 Modular Series System Recall: Operator Injury Risk During Maintenance
Roche recalls cobas 6000 Modular Series systems with specific part numbers and serials to prevent operator injury during maintenance. No remedy is listed in the official notice.
Lower-risk recall
A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance.
Contact the company
Recalling firmRoche Diagnostics Corporation9115 Hague Rd · Indianapolis, IN 46256-1025
What happened, in plain English
Roche is recalling certain cobas 6000 Modular Series systems and related components to prevent operator injury during maintenance. This recall does not include a specific remedy or action for consumers. Read more at govinfonow.com/recall/73402-roche-cobas-6000-modular-series-system-recall-operator-injury-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73402-roche-cobas-6000-modular-series-system-recall-operator-injury-risk · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0909-2018
Cite this page
“Roche cobas 6000 Modular Series System Recall: Operator Injury Risk During Maintenance.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73402-roche-cobas-6000-modular-series-system-recall-operator-injury-risk. Based on FDA recall #Z-0909-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0909-2018%22&limit=1).
Why it’s dangerous
The recall adds a warning to operator manuals to prevent injury during maintenance. This is a procedural safety update rather than a physical hazard that could cause immediate harm.
Who’s affected
Laboratory technicians and medical professionals who use the cobas 6000 Modular Series systems for diagnostic testing. The risk is low as the hazard is related to a warning in operator manuals, not active injury.
How to tell if you have this one
Check if your cobas 6000 Modular Series system has part numbers 04745914001 (cobas c 501 module), 05036453001 (cobas 6000 UL c 501 +), or 05036453692 (cobas 6000 UL + CORE CU). Also check serial numbers listed in the recall notice.
- Brand
Roche- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Distributed in all 50 states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MN, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, and Puerto Rico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0909-2018 | cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V; Serial numbers: 0948-27 0933-27 1214-11 1297-08 0947-23 0932-23 1113-22 16U0-02 16Z4-02 1246-12 1255-08 14F9-15 14F9-16 14M9-15 14M9-16 0963-17 0949-12 0967-13 0953-28 1741-10 14A3-14 14D5-01 14D5-17 14K0-17 1163-13 1163-14 1146-13 1146-14 1166-18 1149-18 1146-15 1148-16 1113-25 1113-26 1157-01 1157-02 1113-13 1113-14 16Z6-02 0809-22 0888-22 0762-15 0770-07 0756-15 0770-14 0756-22 0825-28 0806-28 1175-11 1161-11 0809-29 0888-29 15K6-10 15U2-10 0626-07 0748-13 0749-10 0629-12 0747-01 14J2-18 1243-13 1247-09 14D7-16 14D7-18 14K3-16 14K3-18 14C0-06 14G5-18 14F9-18 14G3-19 14M9-18 14P2-19 14E2-01 14F0-12 14K9-01 14M1-12 0956-15 0941-30 1151-17 1151-18 1123-17 1123-18 0956-06 1147-03 1147-15 1147-16 1112-02 1113-21 0955-29 0941-14 14D8-04 14D8-05 14K5-04 14K5-05 14E4-09 14D8-01 14K5-01 1184-04 1184-05 1174-06 1174-07 0955-21 0955-27 0940-27 0941-12 0813-21 0813-29 0893-22 0893-30 0793-06 0793-07 0776-18 0831-09 0818-29 0793-10 0776-21 0793-09 0776-20 0753-13 0766-11 15G8-04 15P7-04 0772-18 0773-05 0758-15 0758-22 0965-17 0950-25 0817-15 0822-19 0803-19 0896-30 0832-05 0794-11 0777-21 0953-03 0937-24 1214-12 1297-09 15H9-20 15R9-20 0802-13 0881-13 1252-06 1270-01 14D5-09 14K0-09 14B3-13 14F5-14 0783-06 0768-04 1296-09 1296-10 1283-04 1283-05 14C3-10 15J9-13 15S8-08 1246-20 1255-16 0840-24 0825-16 0822-26 0803-26 0822-27 0803-27 16V2-04 16V2-05 1602-04 1602-05 16X0-04 1616-04 16S9-18 16Z3-18 15G8-10 15P7-10 0844-26 0829-26 0953-05 0937-26 0953-29 0938-30 1296-15 1283-10 0840-26 0828-19 0830-01 0813-29 0817-21 15L8-15 15V5-15 0768-05 0835-23 0953-08 0937-29 0958-12 0840-21 0825-13 1250-06 1265-01 15L6-15 14J3-12 0967-07 0953-22 13A1-06 13D1-06 15H9-18 15R9-18 0640-02 0640-13 1172-13 1172-14 1157-13 1157-14 0828-04 0813-14 0828-11 0813-21 0828-02 0813-12 15H9-05 15K0-10 15R9-05 15S9-05 16X4-01 16X4-03 1620-01 1620-03 1208-06 1291-03 14G3-18 14P2-18 14D4-02 14F9-09 14M9-09 1252-03 1269-08 1248-13 1260-09 16R9-01 16R9-02 16Y6-01 16Y6-02 0959-09 0945-14 14B0-04 14F0-16 1183-13 1173-11 1183-12 1173-10 14F9-13 14M9-13 14F9-14 14M9-14 14F8-20 14G0-03 15L8-07 15L8-09 15V5-07 15V5-09 14G2-03 14J3-11 16U0-05 16Z4-05 14A8-02 14B3-10 14F5-11 14B2-11 14D7-17 14K3-17 1356-12 1379-04 16S2-07 1249-19 1249-20 1263-11 1263-12 1236-01 1358-10 1380-06 1233-14 1252-19 1371-04 1233-13 1252-18 1371-03 1175-16 1161-16 1151-19 1123-19 1127-11 1182-11 1182-12 1172-09 1172-10 0808-26 0887-24 15P2-09 15P2-10 15W9-09 15W9-10 1145-20 1146-14 1113-27 1113-29 0817-09 0896-24 0812-30 0892-05 0967-08 0953-23 1250-07 1265-02 16W1-08 16W1-09 1610-08 1610-09 0822-22 0822-28 0803-22 0803-28 0946-12 0946-14 0946-15 0840-25 0840-27 0840-30 0825-17 0825-19 0825-22 1361-04 1384-10 16V7-17 1606-17 1619-06 1175-19 1175-20 1161-19 1161-20 0639-13 0640-04 0809-28 0888-28 0820-19 0813-25 0893-26 1169-16 1175-13 1161-13 1169-15 1157-18 14A9-09 14E8-11 0804-30 0883-15 0948-26 0933-26 15H9-10 15R9-10 14B1-08 14F3-02 16V9-04 1608-04 14B5-13 14B5-14 14F8-13 14F8-14 1174-17 1174-18 1160-17 1160-18 1241-03 1251-17 1251-20 1269-02 1269-05 0625-16 0629-01 0636-10 0637-21 0793-19 0776-30 1253-05 1371-10 16U5-03 16Z6-03 16V9-02 1608-02 0837-05 0822-30 0939-09 0821-28 0802-09 0776-15 0762-14 0953-19 0938-20 1182-08 1184-08 1172-06 1174-10 15G8-05 15P7-05 1184-06 1174-08 16W1-06 1610-06 16Z1-06 16Z2-01 1632-06 1633-01 0773-04 0773-10 0758-21 0758-27 0817-22 1295-03 1220-03 1255-12 14C0-05 14C1-06 14G5-17 14G9-02 14F3-05 14F3-06 14M4-05 14M4-06 0612-05 0612-05 0640-10 0640-21 16P7-10 16V2-07 16V8-12 1602-07 1607-12 16V8-16 1607-16 1242-06 1243-11 0831-01 0831-05 0840-28 0840-29 0825-20 0825-21 0828-05 0828-06 0813-15 0813-16 1188-11 1188-12 1177-10 1177-11 0948-25 0933-25 0752-13 0748-04 0836-09 0821-29 0952-30 0937-21 0953-16 0938-17 0953-11 0938-12 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0804-29 0883-14 1214-08 1297-05 0777-02 0762-21 0639-11 0640-02 1160-09 1117-04 1155-09 1132-08 1173-16 1173-17 1158-12 1158-13 0958-05 0944-03 0958-06 0944-04 0981-10 1014-02 1014-03 1083-23 1083-24 14A9-10 14E8-12 1356-09 1379-01 0627-20 0624-16 1221-16 1207-14 15H9-17 15R9-17 16R2-12 16Y0-12 1250-09 1265-04 0955-25 0941-01 14A5-12 14D9-19 14F9-12 14M9-12 1290-13 1221-13 1207-11 1246-17 1255-13 15P3-07 16U0-01 16Z4-01 0953-10 0938-11 16V7-14 16V7-15 1606-14 1606-15 16V7-16 1606-16 16S0-19 16X4-02 1620-02 0897-08 0804-21 0883-06 1395-03 13B7-11 1395-04 13B7-12 0809-21 0809-25 0888-21 0888-25 0814-10 0814-27 0805-26 0805-27 0884-11 0884-12 1182-09 1172-07 1290-09 1179-07 0967-15 0953-30 62024 14C1-07 14G9-03 1246-14 1246-15 1255-10 1255-11 0899-01 0880-01 1250-14 1265-09 14D4-19 0844-25 0829-25 0959-14 0959-17 0945-19 0945-22 1242-11 1243-16 1231-05 1242-12 1243-17 16V2-20 16V3-01 1602-20 1603-01 14B1-10 14B1-11 14F3-07 14F3-08 0636-18 0637-29 0770-19 14G0-05 15L8-02 15L8-08 15V5-02 15V5-08 0829-22 0844-22 0790-20 0783-04 0768-02 1250-15 1265-10 0639-06 0758-06 16V2-09 16V2-10 1602-09 1602-10 14A9-12 14E8-14 0772-11 0758-08 0772-16 0758-13 1394-09 1394-10 13B6-17 13B6-18 1232-14 0813-23 0893-24 1251-15 1268-10 0758-14 0766-06 0749-24 0753-08 14D7-19 14K3-19 14D7-20 14K3-20 0955-18 0956-01 0940-24 0941-16 0883-04 1246-18 1255-14 1146-13 1117-17 16W1-11 1610-11 0763-05 0772-12 0758-09 0826-28 0807-28 16X0-09 1616-09 0954-08 0939-16 14F9-08 14M9-08 14B5-08 14F8-08 14A5-15 14E0-02 1029-14 1099-11 0897-13 0783-13 0768-11 0802-19 0881-19 15K0-06 15S9-01 1251-12 1268-07 1377-11 1395-06 13B7-14 1171-18 1188-07 1214-17 1296-11 1177-06 1283-06 1297-14 16V7-06 16V7-07 1606-06 1606-07 0817-06 0817-07 0896-21 0896-22 0953-27 0938-28 14F0-06 16V9-03 1608-03 0770-16 0756-24 1242-08 1243-13 0618-16 0618-18 618-20 619-02 16R9-11 16Y6-11 16R9-12 16Y6-12 1253-03 1253-04 1371-08 1371-09 1741-05 1251-18 1251-19 1269-03 1269-04 1221-17 1207-15 0830-08 0817-28 14G3-01 14P2-01 16Z1-17 1291-19 1292-03 1219-01 1219-02 1176-15 1176-16 1162-11 1162-12 1188-09 1188-10 1177-08 1177-09 1214-13 1214-15 1297-10 1297-12 1175-17 1175-18 1161-17 1161-18 1358-14 1358-15 1359-07 1380-10 1380-11 1382-17 1026-04 1094-25 1146-09 1117-13 16R2-01 16Y0-01 1358-13 1380-09 1157-03 1157-05 1113-19 1113-20 0817-28 16V2-08 1602-08 16W1-05 1610-05 16V7-09 1606-09 1159-15 1136-20 1017-09 1087-07 0826-03 0945-21 0945-22 0930-21 0930-22 1152-17 1152-18 1127-12 1127-13 1208-08 1291-05 1252-12 1270-07 15K6-09 15U2-09 1155-12 1155-13 1132-11 1132-12 1160-02 1149-11 15J9-17 15S8-12 1159-13 1136-18 0828-20 0813-30 0642-06 0641-26 14F3-07 14M4-07 14M4-08 14D5-18 14D5-19 14K0-18 14K0-19 0641-15 14B2-13 14D5-10 14D5-11 14K0-10 14K0-11 0899-03 0880-03 14B3-09 14F5-10 14B2-12 14D8-03 14K5-03 1358-09 1380-05 1298-17 1222-15 1150-05 1150-06 1121-16 1121-17 0955-24 0940-30 0955-26 0941-02 0774-17 0760-25 0805-24 0884-09 15M6-19 15W5-19 15M6-18 15W5-18 0637-12 0638-13 0623-12 0626-26 0626-01 0774-18 0760-26 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0758-13 0758-12 0954-09 0939-17 15J4-08 15S3-08 0758-02 0749-12 0776-16 14D4-04 14F3-09 14M4-09 14D5-07 14K0-07 14E3-08 15H9-19 15R9-19 15J4-06 15S3-06 15J4-02 15S3-02 0784-06 0769-16 16U6-01 16U6-02 16Z7-01 16Z7-02 14E4-07 15J4-14 15S3-14 1214-09 1297-06 1221-14 1207-12 1245-18 1252-14 14B3-02 14D5-20 14K0-20 16V7-10 1606-10 0955-17 0940-23 0817-29 0897-24 16R2-16 16Y0-16 0639-02 0639-23 0954-07 0939-15 16U5-07 16U5-08 16Z6-07 16Z6-08 1242-05 1243-10 14F9-10 14M9-10 1183-14 1173-12 16S9-10 16Z3-10 14B5-09 14F8-09 15H9-14 15J4-10 15R9-14 15S3-10 15J9-07 15J9-10 15S8-02 15S8-05 15J9-06 15J9-11 15S8-01 15S8-06 16R2-11 16Y0-11 0747-20 0746-01 0637-18 0638-19 0804-24 0883-09 1164-13 1182-07 1172-05 1215-14 1298-10 14F3-14 14M4-14 0783-17 0768-15 0768-03 0754-25 0631-01 0633-12 15H9-07 15R9-07 14E4-03 15K6-12 15U2-12 0776-12 0762-11 0783-20 14G3-05 14P2-05 15K6-13 15K6-14 15U2-13 15U2-14 15H9-13 15J4-15 15R9-13 15S3-15 1175-14 1175-15 1161-14 1161-15 15J4-18 15S3-18 1215-18 1298-14 1032-13 1032-14 1003-26 1003-27 0817-01 0896-16 15P2-01 15W9-01 16U5-16 16Z6-16 14E2-09 14F0-01 14K9-09 14M1-01 0630-02 0632-13 15J4-03 15S3-03 15G8-14 15P7-14 1245-13 1245-14 1245-15 1252-09 1252-10 1252-11 1741-08 0813-28 0817-10 0893-29 0896-25 0964-06 1017-03 1017-10 1087-01 1087-08 15K6-06 15U2-06 1250-01 1250-02 1263-13 1263-14 1019-16 1088-29 1143-08 1115-02 0981-01 0965-18 0950-26 16U0-12 16U0-13 16Z4-12 16Z4-13 16S9-13 16U0-10 16Z3-13 16Z4-10 16S0-07 16W1-01 1610-01 1204-06 1378-07 1380-12 13C2-07 13C2-08 0958-08 0944-06 1247-04 1247-05 1390-05 13B2-20 14D5-14 14K0-14 14E2-12 14E2-13 14K9-12 14K9-13 16R2-02 16Y0-02 16R8-08 16V8-20 1607-20 16R8-07 16V7-18 1606-18 1243-08 1243-09 0958-03 0944-01 1248-14 1260-10 | 3433 |
| Z-0910-2018 | cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module; Serial Numbers: 16C4-09 1475-01 1476-05 15A1-03 15A1-05 16B3-10 1474-06 1138-10 1140-10 1485-06 1590-01 1475-05 1484-05 1484-06 1012-06 1482-02 1481-10 1254-07 1487-07 1482-09 1482-10 16B7-08 16B8-06 1010-03 1020-09 15A2-02 1247-02 1267-06 15A2-03 1267-01 1369-02 16B5-08 16B3-03 15A5-04 15A5-03 1124-03 1125-04 1591-04 1591-05 1474-09 1474-08 1009-05 1021-08 1139-03 1140-09 1267-02 1267-03 1140-06 16B1-02 16B1-03 1138-04 1138-09 16B4-03 16C3-03 1485-07 1597-09 1011-10 1018-10 16C7-08 16C4-07 1475-02 1475-04 1476-07 16C4-10 16C5-10 15A4-04 15A4-05 1267-07 1474-07 1266-08 1267-09 1256-02 1256-03 1125-05 1369-08 15A6-04 15A7-03 1020-05 1124-04 1123-08 1485-09 1597-04 15A0-03 16C1-05 16C1-06 16C1-07 1267-08 1594-02 1594-04 1594-05 1594-06 1595-01 1595-06 1597-02 1597-03 15A3-01 15A4-01 16B0-02 16B0-03 16B0-04 16B8-03 16B8-04 16B5-09 16B8-01 16B2-07 16B2-08 1266-06 1266-07 1591-01 1591-02 16B1-07 16B2-05 16B2-06 16B1-01 16B4-10 16B5-01 15A6-02 15A6-03 15A6-06 1253-06 16B5-04 16B5-05 1592-01 1592-06 1592-07 16C7-09 16D0-10 1138-07 1139-05 16B1-04 16B1-05 1369-04 1124-05 1124-06 1139-01 1139-02 1253-04 1253-03 1251-03 1251-07 1482-03 1483-07 16C2-03 16B0-05 16B0-06 16B0-01 1124-09 1124-10 15A5-02 16A9-06 1017-04 1122-04 16C5-03 1483-09 1483-10 15A4-06 1012-08 1131-02 1131-03 1137-08 1139-04 1592-10 1597-06 1597-07 1597-08 16B4-01 16B4-02 16B6-05 16C3-04 16C4-06 16B7-05 16B7-06 1476-04 1475-03 16B8-05 16B8-09 1139-06 1591-07 16C1-04 1135-02 1137-07 1266-09 1266-03 1267-04 1472-05 1592-09 1592-08 1138-05 1266-05 1254-09 1254-10 1485-05 1019-03 1132-03 1472-02 1474-10 1132-04 1132-05 1021-04 1021-06 1247-01 1253-07 1472-03 1472-04 1477-06 1482-06 16C8-02 16C8-03 16B1-06 16B7-07 16B5-07 16B8-07 15A1-06 15A1-08 15A5-01 16B2-09 16B3-02 15A6-05 16A9-05 1123-05 1125-03 1251-06 1266-10 1140-07 1140-08 1254-08 1125-02 1132-09 16C1-10 16C1-09 1267-05 1253-05 1483-06 1483-08 1132-07 1133-09 16C1-02 1484-10 1484-09 1484-08 16C5-01 1015-07 1018-09 1123-06 16B6-04 | 245 |
What to do — step by step
Check Your Equipment
Verify if your cobas 6000 Modular Series system has the listed part numbers or serial numbers from the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 49 states.
FDA distribution: “Distributed in all 50 states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MN, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0909-2018 (July 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0909-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.