Device Recall BD Affirm VPIII Microbial Identification Tests 의 리콜

Recall

65619

Class 2

Z-1812-2013

2013-06-13

2013-07-26

Terminated

United States

2013-09-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119730

In vitro diagnostic test kit may exhibit invalid internal negative control results.

Becton Dickinson Diagnostic Systems notified distributors by fax on June 13, 2013, and advised consignees to discontinue use and discard affected product for credit. Distributors were requested to return their distribution list to BD for direct notification by the recaller. End users were contacted by letter on June 13, 2013 and the notification addressed to Microbiology Lab Director/Risk Managers advised that a small number of tests associated with the referenced lots of product may exhibit invalid internal negative control results. If encountered, the issue would result in an invalid test, as described in the package insert. End users were requested to discontinue use of these lot numbers, discard any remaining packages for replacement and return the enclosed response form. Customers with questions were instructed to contact BD Technical Services Department at 1-800-638-8663. For assistance regarding replacements customers were instructed to contact BD Customer Service at 1-800-675-0908. For questions regarding this recall call 410-316-4054.