RecallRadar

FDA Device recall Z-1233-2019

Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398

On 2019-05-08 the FDA classified a Class II recall of Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398 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

AgencyFDA Device
Recall numberZ-1233-2019
ClassificationClass II
Statusterminated
Initiated2018-12-07
Published2019-05-08
Last updated2026-09-13 11:55 UTC
CompanySiemens Healthcare Diagnostics
DistributionUS

Product

Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398

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: 68748302 12/13/2018 68749302 12/13/2018 83577304 1/12/2019 88637304 1/12/2019 5610306…Lot Number/Exp. Date: 68748302 12/13/2018 68749302 12/13/2018 83577304 1/12/2019 88637304 1/12/2019 5610306 2/11/2019 96436306 2/11/2019 19097308 3/14/2019 31866310 4/27/2019 45386310 4/27/2019 55627312 5/27/2019 69208316 6/29/2019 73000316 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-1233-2019%22

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