Lower riskMedical device recall · FDA · Published July 23, 2019
Roche cobas c 311/501/502: Inaccurate vancomycin test results
Roche recalls vancomycin testing devices that may give low sample results. Affected units include cobas c 311 and cobas c 501/502 analyzers with catalog # 06779336190.
“Roche cobas c 311/501/502: Inaccurate vancomycin test results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67359-roche-cobas-c-311-501-502-inaccurate-vancomycin-test-results. Based on FDA recall #Z-0042-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0042-2020%22&limit=1).
Roche Diagnostics Operations, Inc. voluntarily recalled Online TDM Vancomycin Gen.3 (100 tests) due to a hazard of inaccurately low sample results, according to the Food and Drug Administration on July 23, 2019.
How to tell if you have it
Brand: Roche
Product: Online TDM Vancomycin Gen.3 (100 tests)
Catalog #: 06779336190
Analyzer/Module: cobas c 311 and cobas c 501/502
Lots: All Lots
The hazard
The recall addresses the hazard of inaccurately low sample results, according to the FDA.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has 32 other recalls on record since July 2, 2019. Other recent recalls of similar products include Roche cobas pro integrated solutions recall (Jan. 20, 2026), Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), and Roche cobas HCYS Assay Recall (Oct. 17, 2024).
How to tell if you have this one
Check for the catalog number 06779336190 on the device. The affected models are cobas c 311 and cobas c 501/502 analyzers used for vancomycin testing.
Brand
Roche
Category
Medical device
FDA recall event · 2 products
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
AK AL AR AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY
Recall number
Product, codes & lots
Quantity
Z-0042-2020
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502; All Lots
27676 units
Z-0043-2020
Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502; All Lots
33979 units
Based on the official FDA remedy
What to do — step by step
Check Device Model
Look for the catalog number 06779336190 on the cobas c 311 or cobas c 501/502 analyzer.
Where it went and when
Where it was distributed
Distributed in 49 states and D.C. and Puerto Rico.
Listed by the agency
Not listed
FDA distribution: “AK AL AR AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, 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 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0042-2020 (July 23, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0042-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.