BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, D

FDA device recall Z-0523-2013 · posted 2012-12-13 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens.

Action taken

BD Diagnostic Systems sent an Urgent Product Recall letter dated October 22, 2012, to all affected customers.. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to discontinue distribution and discard affected inventory for credit. . Customers were requested to return a response form by fax to 410-316-4258. For questions customers were instructed to contact BD Customer Service Department at 1-800-638-8663. For assistance with replacements, customers were instructed to call 1-800-675-0908. For questions regarding this recall call 410-316-4258.

Root cause

Employee error

Status

Terminated

Product code

GRO

Quantity affected

650 vials

Distribution

Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico

Date initiated

2012-10-22

Date posted

2012-12-13

Date terminated

2013-01-24

Location

Sparks, MD