Reported May 8, 2019 · Terminated
Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc · 333 Coney St · East Walpole, MA · 02032-1516
Is this the product you have?
- Siemens ADVIA Centaur aTG (100
- test kit) Siemens Material Number (SMN)10492398
- Lot codes and dates
- Lot Number/Exp
- Date
6874830212/13/20186874930212/13/2018835773041/12/2019886373041/12/201956103062/11/2019964363062/11/2019190973083/14/2019318663104/27/2019453863104/27/2019556273125/27/2019692083166/29/2019730003166/29/2019
- Amount recalled
- 10673 kits
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
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).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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