Reported Jun 12, 2013 · Terminated
ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the…
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¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published — Lot Number/Exp. Date 10492369-500 Tests 61639301 09 Nov 2011 REF 1 0493615 - 500 Tests 63607301 09 Nov 2011 68004301 09 Nov 2011 70229301 09 Nov 2011 74126301 09Nov2011 10493616-500Tests 62645302 09 Nov 2011 66612302 09 Nov 2011 74129302 09 Nov 2011 - Amount recalled
- 3302 Kits (500 test)
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
- Nationwide
Why it was recalled
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
This product could cause temporary or reversible health problems — stop using it.
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