Atellica IM BR 27 — Class II medical device recall Z-2426-2021
Ongoing recall by Siemens Healthcare Diagnostics, Inc, reported 2021-09-15, distributed nationwide. Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibra
| Recall number | Z-2426-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2021-07-06 |
| Classified | 2021-09-03 |
| Reported by FDA | 2021-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BS, IN, MX, SA, VN |
| Quantity | 787 units |
| Lot numbers | 41331255, 74682255, 91605257 |
| Expiration dates | 2021-08-03, 2021-11-10 |
Product
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236
Reason for recall
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2426-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.