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Siemens Healthcare Diagnostics, Inc recalls SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
Recalled May 8, 2019 · FDA recall Z-1234-2019 · Siemens Healthcare Diagnostics
Hazard
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). · FDA Class II
Units
10414 kits
Sold at
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Description
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).
Product
SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →