Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1458-05

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

Becton Dickinson & Co / initiated 2005-07-28 / Terminated

Becton Dickinson & Co. began a recall of Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box on . The reason FDA records is "Microbiological media for antibiotic susceptibility testing gives false test results". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1458-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box.
Product code
JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Reason for recall
Microbiological media for antibiotic susceptibility testing gives false test results.
FDA 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 in commerce
20930 plates
Distribution
Product was sold to distributors and direct account end-users worldwide including government facilities.
Product codes and lots
Lot #5140549, EXP 8/17/05