Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0069-04

Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and 100 per...

Remel Inc / initiated 2003-10-02 / Terminated

Remel, Inc began a recall of Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and 100 per case (Cat. #01886). The responsible firm on the... on . The reason FDA records is "Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0069-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Remel Inc
Product
Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and 100 per case (Cat. #01886). The responsible firm on the label is Remel, Lenexa, KS.
Product code
JTY Culture Media, For Isolation Of Pathogenic Neisseria
Reason for recall
Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae
FDA root cause
Other
Action
The recalling firm initiated recall via letter dated 10/2/03 issued regular mail requesting the customer destroy remaining inventory of the affected lot numbers.
Quantity in commerce
404/10-pks; 67/15-pks; and 33/100-pkg. cases
Distribution
Distribution was made nationwide to facilities with medical laboratories, including military and government facilities.
Product codes and lots
10 pack - Lot #384341, Exp. 11/03/2003; 15 pack - Lot #384342, Exp. 11/3/2003; 100/cs - Lot #384343