| | Class 2 Recall
BD BBL Taxo XV Factor Strips |  |
| Date Posted |
December 13, 2012 |
| Recall Number |
Z-0523-2013 |
| Product |
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*** |
| Code Information |
Lot number 2089253
|
Recalling Firm/
Manufacturer |
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks, Maryland 21152-0999 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Ms. Gail Claiborne
410-316-4054
|
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 |
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. |
| Quantity in Commerce |
650 vials |
| Distribution |
Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico |
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