Oxoid CM0225 Brain Heart Infusion IVD. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. The pr
FDA device recall Z-0979-2010 · posted 2010-03-09 · Terminated
Recall details
- Recalling firm
- Remel, Inc
- Reason for recall
- Product failure - Failure to grow quality control strains of Streptococcus pneumoniae.
- Action taken
- 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
- Status
- Terminated
- Product code
- JSC
- Quantity affected
- 105 bottles
- Distribution
- United States (FL, NY, MO, NY, DE, and PA).
- Date initiated
- 2009-12-21
- Date posted
- 2010-03-09
- Date terminated
- 2011-07-12
- Location
- Lenexa, KS
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