medical Class II Updated 2019-05-08

Siemens Healthcare Diagnostics, Inc recalls Atellica IM aTG (500 test kit) Siemens Material Number (SM

Recalled Product

Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462

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 or lower) 56683313 5/27/2019 70390317 6/29/2019
View official government recall

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