FDA Device recall Z-1235-2019
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
- FDA Device
- Class II
- terminated
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class II recall of Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461 by Siemens Healthcare Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1235-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-07 |
| Published | 2019-05-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
Reason
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).
Identifiers
| code_info | Lot Number/Exp. Date: kit lots ending in 317 and lower 72259303 12/13/2018 87903305 1/12/2019 94908307 2/11/2019 96…Lot Number/Exp. Date: kit lots ending in 317 and lower 72259303 12/13/2018 87903305 1/12/2019 94908307 2/11/2019 96439307 2/11/2019 16824309 3/14/2019 25822309 3/14/2019 28942311 4/27/2019 55978313 5/27/2019 70389317 6/29/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1235-2019%22
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