Recall Z-0979-2010 ยท JSC Culture Media, General Nutrient Broth
Remel, Inc
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.
| Date | Mar 9, 2010 (initiated Dec 21, 2009) |
| Status | Terminated |
| Reason | Product failure - Failure to grow quality control strains of Streptococcus pneumoniae. |
| Root cause | Other |
| 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). |
| Quantity | 105 bottles |
| Distribution | United States (FL, NY, MO, NY, DE, and PA). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.