Lower riskMedical device recall · FDA · Published May 13, 2021
Siemens Atellica IM 1300 Analyzer Recall: Valve Leaks Risk Test Accuracy
Siemens Healthcare recalls Atellica IM 1300 analyzers due to valve leaks that may cause inaccurate test results. Affected units have specific serial numbers and model ranges. Contact for repair or replacement.
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.
“Siemens Atellica IM 1300 Analyzer Recall: Valve Leaks Risk Test Accuracy.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62545-siemens-atellica-im-1300-analyzer-recall-valve-leaks-risk-test. Based on FDA recall #Z-2027-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2027-2021%22&limit=1).
The FDA announced on May 13, 2021, that Siemens Healthcare Diagnostics, Inc. is recalling the Atellica IM 1300 Analyzer due to valves that may leak and impact assay result accuracy. This voluntary Class II recall affects units distributed nationwide and internationally.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica IM 1300 Analyzer
SMN: 11066001
Serial Range: IM00873-IM01452 and IRM00256xxxx-IRM01169xxxx (where xxxx is any number)
UDI: 00630414007960
The hazard
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect. This can cause the valve to wear and leak over time, creating a risk in valves subject to high pressure or high wear that may impact the result accuracy of any assay.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls on record since June 7, 2017. Other recent recalls include the Siemens Atellica CH RCRP Test recall from August 17, 2026, and the Siemens Atellica CH Urine Albumin Recall from July 6, 2026. Similar recent recalls of other products include the Philips Integris-Allura System Recall (April 28, 2026), the On-X Mitral Heart Valve Recall (February 1, 2026), and the Baxter VOLARA System Recall (August 3, 2026).
How to tell if you have this one
Check for serial numbers starting with IM00873, IM01452, IRM00256xxxx, or IRM01169xxxx (where xxxx is any number). The UDI is 00630414007960.
Brand
Siemens Healthcare
Category
Medical device
FDA recall event · 3 products
All 3 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
Ongoing
Distribution
Nationwide Foreign: Country Name Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile Colombia Croatia Cura¿ao Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece Hungary India Indonesia Iraq Ireland Israel Italy Japan Kenya Kuwait Latvia Libya Lithuania Malaysia Mexico Morocco Netherlands New Zealand Norway Oman P.R. China Pakistan Peru Philippines Poland Portugal Qatar Republic Korea Romania Russian Fed. Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. Uganda Ukraine United Kingdom Uruguay Vatikancity Vietnam
Recall number
Product, codes & lots
Quantity
Z-2026-2021
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000; Effected SN Range: CM00902 - CM02065 Note: xxxx in serial number is any number. UDI: 00630414002163
US: 210 OUS: 874
Z-2027-2021
Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001; Effected Serial Range: IM00873 IM01452 and IRM00256xxxx IRM01169xxxx Note: xxxx in serial number is any number. UDI: 00630414007960
US: 233 OUS: 233
Z-2028-2021
Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000; Effected serial range: IH00876 IH01451 and IRH00258xxxx IRH01169xxxx Note: xxxx in serial number is any number. UDI: 00630414002026
US: 123 OUS: 751
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Look for specific serial numbers in the affected ranges: IM00873, IM01452, IRM00256xxxx, or IRM01169xxxx (xxxx is any number).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide Foreign: Country Name Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile Colombia Croatia Cura¿ao Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-2027-2021 (May 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2027-2021 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.