Recalls / —
—#87805
Product
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 product code
- JSC — Culture Media, General Nutrient Broth
- Device class
- Class 1
- Medical specialty
- Microbiology
- Affected lot / code info
- Lot numbers 762134, Exp. 2014.04.30; 793640, Exp. 2014.07.31; and 819693, Exp. 2014.10.31
Why it was recalled
Product failure - Failure to grow quality control strains of Streptococcus pneumoniae.
Root cause (FDA determination)
Other
Action the firm took
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).
Recalling firm
- Firm
- Remel, Inc
- Address
- 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519
Distribution
- Distribution pattern
- United States (FL, NY, MO, NY, DE, and PA).
Timeline
- Recall initiated
- 2009-12-21
- Posted by FDA
- 2010-03-09
- Terminated
- 2011-07-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #87805. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.