FDAFDA · Food and drugs·Recall number Z-1022-2013
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
Published April 3, 2013 · Recall initiated: February 4, 2013
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
Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an invalid assay is obtained, those results should not be reported and the test should be re-run. An invalid assay would not result in significant harm to a pati
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Genetic Testing Institute,inc
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
- Lot
- Kit Lot Number 3000389
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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