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.
FDA Recall Z-0979-2010 · Posted 2010-03-09
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Recalling FirmRemel, Inc
Recall StatusTerminated
Product CodeJSC
Date Initiated2009-12-21
Date Terminated2011-07-12
Product Quantity105 bottles
Reason for Recall
Product failure - Failure to grow quality control strains of Streptococcus pneumoniae.
Firm 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).
Root Cause
Other
Distribution Pattern
United States (FL, NY, MO, NY, DE, and PA).
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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