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Terminated

Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box.

FDA Recall Z-1458-05 · Posted 2005-08-31

Recall StatusTerminated
Product CodeJTZ
Date Initiated2005-07-28
Date Terminated2005-10-17
Product Quantity20930 plates

Reason for Recall

Microbiological media for antibiotic susceptibility testing gives false test results.

Firm 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.

Root Cause

Other

Distribution Pattern

Product was sold to distributors and direct account end-users worldwide including government facilities.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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