Genetic Testing Institute,inc: Medical Device Recall in 2013 - (Recall #: Z-1022-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: February 4, 2013

Date Posted: April 3, 2013

Recall Number: Z-1022-2013

Event ID: 64501

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

Status: Terminated

Product Quantity: 386 kits (370 US, 16 OUS)

Code Information:

Kit Lot Number 3000389

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated