Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1235-2019 — Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461

U.S. FDA — Device Enforcement · United States · 2018-12-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1235-2019
Date of alert
2018-12-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
72259303
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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