Reported Jul 9, 2014 · Terminated
ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN…
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?
ADVIA Centaur¿ Systems TnI-Ultra assayCatalog Number 02789602 (100 tests)SMN 10317708 and 02790309 (500 tests)SMN 10317790
- Lot codes and dates
- Kit Lots Ending In
078079082083084
- Kit Lots Ending In
- Amount recalled
- 34,283 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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