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

FDA device recall Z-1022-2013 · posted 2013-03-28 · Terminated

Recall details

Recalling firm

Genetic Testing Institute,inc

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

Action taken

Hologic/Gen-Probe sent an Urgent Medical Device Recall letter dated February 4, 2013, via FedEx overnight deliver yto all affected customers. The letter identified affected product, stated the issue, and asked that product from the affected lot stop being used. Reported results for all samples tested using the affected lot should be reviewed. The referring physician should be notified that any negative patient result may be erroneous. Remaining inventory should be returned to Gen-Probe. A response form was also asked to be returned. For questions customers were instructed to contact Technical Support at 262-754-1000 or waukeshatechsupport@gen-probe.com. For questions regarding this recall call 262-754-1026.

Root cause

Process control

Status

Terminated

Product code

LCO

Quantity affected

386 kits (370 US, 16 OUS)

Distribution

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

Date initiated

2013-02-04

Date posted

2013-03-28

Date terminated

2016-03-21

Location

Waukesha, WI

Related 510(k) clearances