—#29927

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.

FDA product code: JTY — Culture Media, For Isolation Of Pathogenic Neisseria
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: 10 pack - Lot #384341, Exp. 11/03/2003; 15 pack - Lot #384342, Exp. 11/3/2003; 100/cs - Lot #384343

Why it was recalled

Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Remel, Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Distribution was made nationwide to facilities with medical laboratories, including military and government facilities.

Timeline

Recall initiated: 2003-10-02
Posted by FDA: 2003-10-24
Terminated: 2004-02-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #29927. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.