Siemens Atellica IM aTG — Class II medical device recall Z-1235-2019
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2019-05-08, distributed nationwide. Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG k
| Recall number | Z-1235-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2018-12-07 |
| Classified | 2019-04-26 |
| Reported by FDA | 2019-05-08 |
| Terminated | 2020-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BR, CH, CL, CZ, DE, DK, ES, FR, GR, HK, HR, IE, IT, PL, PT, SG, SK, TR |
| Quantity | 1,489 kits |
Product
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
Reason for recall
Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use (IFU).
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-1235-2019. 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.