Recall Z-1458-05 ยท JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Becton Dickinson & Co.
Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box.
| Date | Aug 31, 2005 (initiated Jul 28, 2005) |
| Status | Terminated |
| Reason | Microbiological media for antibiotic susceptibility testing gives false test results. |
| Root cause | Other |
| Action | The recalling firm notified distributors and direct accounts by fax, e-mail, and letters on 07/28/2005. The notifications advised of false resistant results with control organisms known to be oxcacillin susceptible. Customers were instructed to discontinue use of the lot and discard for replacement. Distributors were requested to discontinue distribution and provide consignee list for subsequent notification. Response forms are included with the recall letters. |
| Quantity | 20930 plates |
| Distribution | Product was sold to distributors and direct account end-users worldwide including government facilities. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.