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***
This recall has been terminated (originally issued December 13, 2012).
- Recall Initiated
- October 22, 2012
- Posted
- December 13, 2012
- Terminated
- January 24, 2013
- Recall Number
- Z-0523-2013
- Quantity
- 650 vials
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico
Lot / Code Info
Lot number 2089253
Root Cause
Employee error
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.