Recall Z-2141-2011 ยท MJA Susceptibility Test Powders, Antimycobacterial
Becton Dickinson & Co.
BACTEC(tm) MGIT(tm) AST Starter Kit, Catalog 445941. Kit contains 16 each of the 5-Tube and 2-Tube Set Carriers. ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152*** The BACTEC MGIT AST system is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine
| Date | May 5, 2011 (initiated Aug 31, 2010) |
| Status | Terminated |
| Reason | In vitro diagnostic device components are mislabeled. |
| Root cause | Other |
| Action | BD Diagnostic Systems sent an Urgent Product Recall letter on August 31, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter advised customers to discard any carriers or labels that contain the incorrect barcode for replacement. Accounts were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to 410-316-4258. For questions regarding this recall call BD Customer Service at 1-800-675-0908. |
| Quantity | 4123 labels |
| Distribution | Worldwide Distribution - USA including CA, MA, MD, VA and the countries of Argentina, Colombia, Belgium, China, India, Hong Kong, Peru, Singapore, Thailand, and Trinidad. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.