medical Class II Updated 2019-05-08

Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur aTG (100 test kit) Siemens Material N

Recalled Product

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

Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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