Recall Z-2608-2011 ยท JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Becton Dickinson & Co.
BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Ki
| Date | Jun 21, 2011 (initiated Apr 20, 2011) |
| Status | Terminated |
| Reason | Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens. |
| Root cause | Nonconforming Material/Component |
| Action | BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated April 2011 to all affected customers. The letter identifies the product, problem and actions to be taken by the customers. The letter instructed customers to discontinue use of the affected lot number and discard any remaining packages. Customers were requested to complete and return an attached response form via fax at 410-316-4258. The letter states that all discarded product will be replaced. Questions concerning the recall process were directed to BD Customer Service Department at 1-800-675-0908. |
| Quantity | 5440 plates |
| Distribution | Worldwide Distribution--USA (nationwide) and the countries of Canada, Columbia, Jamaica, South Korea, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K863821 | MUELLER HINTON AGAR W/4%NACL AND OXACILLIN Gibco Laboratories Life Technologies, Inc., Oct 9, 1986 |