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Terminated

BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***

FDA Recall Z-0523-2013 · Posted 2012-12-13

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeGRO
Date Initiated2012-10-22
Date Terminated2013-01-24
Product Quantity650 vials

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.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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