Reported Jun 4, 2014 · Terminated
ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for the invitro diagnostic use in…
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 VitD 100 test, Ready Pack
- Catalog Number10491994. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers
- Lot codes and dates
- Kit lots ending in/Exp Date023 07 July 2014 024 08 September 2014 025 08 December 2014 026 09 February 2015 027 10 April 2015
- Amount recalled
- 17,731 kits
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
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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