BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.
FDA device recall Z-1294-03 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- Broth for growing selective bacteria may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate Group B Streptococci.
- Action taken
- Recalling firm notified distributors and end user by letter 8/11/03 and advised of product failure. Consignees were requested to discontinue distribution and use and discard product for replacment. Consignees were requested to return response form.
- Root cause
- Other
- Status
- Terminated
- Product code
- JSD
- Quantity affected
- 860 cartons
- Distribution
- Product was sold to 11 distributors and one end user in the US. Product was additionally distributed to firm''s subsidiaries in Canada and Europe.
- Date initiated
- 2003-08-11
- Date posted
- 2003-10-15
- Date terminated
- 2003-11-19
- Location
- Sparks, MD
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