ClearanceBrief
Recall Z-1294-03 ยท JSD Culture Media, Selective Broth

Becton Dickinson & Co.

BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.

DateOct 15, 2003 (initiated Aug 11, 2003)
StatusTerminated
ReasonBroth for growing selective bacteria may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate Group B Streptococci.
Root causeOther
ActionRecalling 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.
Quantity860 cartons
DistributionProduct was sold to 11 distributors and one end user in the US. Product was additionally distributed to firm''s subsidiaries in Canada and Europe.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.