Device Recall LIFECODES PF4 Enhanced assay 의 리콜

Recall

64501

Class 2

Z-1022-2013

2013-02-04

2013-03-28

Terminated

United States

2016-03-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116359

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.

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.