FDA Device recall Z-1236-2019
Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
- FDA Device
- Class II
- terminated
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class II recall of Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462 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-1236-2019 |
| 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
Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
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 or lower) 56683313 5/27/2019 70390317 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-1236-2019%22
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