FDAFDA · Food and drugs·Recall number Z-1930-2012
Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
Published July 18, 2012 · Recall initiated: May 22, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alere San Diego, Inc.
- Distributor
- Nationwide Distribution
- Lot
- Phase 1: K50708B, W50009B, W50011B, W50012B, W50013B, W50014B, W50016VB, W50021B, W50026B, W50028B, W50030B, W50771B, W50772B, W50773B, W50774B, W50778B, and W50801B. Phase 2: W50015B, W50029B, and W50788B.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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