medical Class II Updated 2019-05-08

Siemens Healthcare Diagnostics, Inc recalls SiemensADVIA Centaur aTG (500 test kit) Siemens Material Nu

Recalled Product

SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399

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 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
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