Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0621-2007

Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label...

Remel Inc / initiated 2007-02-21 / Terminated

Remel, Inc. began a recall of Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS on . The reason FDA records is "False negative results for sorbitol fermenting bacteria such as E. Coli 0157". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0621-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Remel Inc
Product
Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS.
Product code
JSI Culture Media, Selective And Differential
Reason for recall
False negative results for sorbitol fermenting bacteria such as E. Coli 0157.
FDA root cause
Other
Action
Recall letters dated 2/19/07 were issued on 2/21/07 via regular mail explaining the reason for recall and requesting all remaining inventory of the affected lot be discarded. A Product Inventory Checklist was enclosed to indicate the amount of inventory the customer discarded. This was to be returned via FAX or mail in the return envelope provided.
Quantity in commerce
694/10-pack boxes
Distribution
Nationwide.
Product codes and lots
Lot 506069, Exp. 2007/03/20