Siemens Healthcare Diagnostics, Inc recalls Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461

Recall date

December 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1235-2019

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc

Sold / distributed

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Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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