FDA Recall Terminated

Oxoid CM0225 Brain Heart Infusion IVD. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. The product is used for the cultivation of streptococci, pneumococci, meningococci and other fastidious organisms and is suitable for blood culture work.

Recall: Z-0979-2010 · Initiated December 21, 2009

Recall

Recall Number
Z-0979-2010
Event Number
54194
Firm
Remel, Inc
FEI Number
1924669
Product Code
JSC
Status
Terminated
Root Cause
Other
Initiated
December 21, 2009
Posted
March 9, 2010
Terminated
July 12, 2011
Address
12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

Description

Oxoid CM0225 Brain Heart Infusion IVD. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. The product is used for the cultivation of streptococci, pneumococci, meningococci and other fastidious organisms and is suitable for blood culture work.

Reason

Product failure - Failure to grow quality control strains of Streptococcus pneumoniae.

Action

The recalling firm issued separate recall letters dated December 21, 2009 addressed to Microbiology Laboratory Supervisors or Distributors explaining the reason for recall and requesting all remaining product be discarded. A Product Inventory Checklist was enclosed to report the amount of product that was discarded by the customer. The Distributor letter requests the consignee contact their customers to notify them of the recall. Direct inquiries concerning this recall to the Technical Services Department at 1-800-255-6730 (United States) or 1-913-888-0939 (International).

Distribution

United States (FL, NY, MO, NY, DE, and PA).

Quantity

105 bottles