medical Class II Updated 2019-05-08

Siemens Healthcare Diagnostics, Inc recalls Siemens Atellica IM aTG (100 test kit) Siemens Material Nu

Recalled Product

Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461

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: 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
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