Home / Recalls / Genetic Testing Institute,inc / Z-1022-2013

Z-1022-2013 Class II Terminated

Recalled by Genetic Testing Institute,inc — Waukesha, WI

Recall Details

Product Type: Devices
Report Date: April 3, 2013
Initiation Date: February 4, 2013
Termination Date: March 21, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 386 kits (370 US, 16 OUS)

Product Description

Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).

Reason for Recall

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

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.

Code Information

Kit Lot Number 3000389