Z-0979-2010

Oxoid CM0225 Brain Heart Infusion IVD. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire...

Name: Z-0979-2010 Oxoid CM0225 Brain Heart Infusion IVD. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire...
Creator: Remel, Inc
Published: 2009-12-21
License: https://open.fda.gov/license/

Remel Inc / initiated 2009-12-21 / Terminated

FDA source

Remel, Inc began a recall of 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... on 2009-12-21. The reason FDA records is "Product failure - Failure to grow quality control strains of Streptococcus pneumoniae". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0979-2010
Status: Terminated
Initiated: 2009-12-21
Posted: 2010-03-09
Terminated: 2011-07-12
Recalling firm: Remel Inc
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.
Product code: JSC Culture Media, General Nutrient Broth
Reason for recall: Product failure - Failure to grow quality control strains of Streptococcus pneumoniae.
FDA 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 in commerce: 105 bottles
Distribution: United States (FL, NY, MO, NY, DE, and PA).
Product codes and lots: Lot numbers 762134, Exp. 2014.04.30; 793640, Exp. 2014.07.31; and 819693, Exp. 2014.10.31

Product code JSC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)