FDA Device recall Z-1234-2019
SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
- FDA Device
- Class II
- terminated
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class II recall of SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399 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-1234-2019 |
| 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
SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
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 316 or lower) 68750302 12/13/2018 68751302 12/13/2018 83578304 1/12/2019…Lot Number/Exp. Date: (Kit Lots ending in 316 or lower) 68750302 12/13/2018 68751302 12/13/2018 83578304 1/12/2019 91382304 1/12/2019 4642306 2/11/2019 8116306 2/11/2019 19098308 3/14/2019 22635308 3/14/2019 33640310 4/27/2019 39133310 4/27/2019 55625312 5/27/2019 55626312 5/27/2019 56285312 5/27/2019 69206316 6/29/2019 73001316 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-1234-2019%22
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