Recalls / —

—#41123

Product

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

FDA product code

JTZ — Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

Device class

Class 2

Medical specialty

Microbiology

Affected lot / code info

Lot #5140549, EXP 8/17/05

Why it was recalled

Microbiological media for antibiotic susceptibility testing gives false test results.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Becton Dickinson & Co.

Address

7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern

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

Timeline

Recall initiated

2005-07-28

Posted by FDA

2005-08-31

Terminated

2005-10-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #41123. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.