Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0024-05

Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on...

Remel Inc / initiated 2004-09-27 / Terminated

Remel, Inc. began a recall of Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS on . The reason FDA records is "The product does not perform as intended with some quality control organisms (Haemophilus influenzae)". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0024-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Remel Inc
Product
Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.
Product code
KZI Culture Media, Enriched
Reason for recall
The product does not perform as intended with some quality control organisms (Haemophilus influenzae)
FDA root cause
Other
Action
The recalling firm notified their customers via telephone on 9/27/04 requesting they examine their inventory and discard the recalled lot.
Quantity in commerce
4,620 units (308 packages)
Distribution
Distribution was made to medical facilities and laboratories located in IA, KS, MO, FL, NY, IL, AR, TX, and OK.
Product codes and lots
Lot #435902, Exp. 2004-11-04