—#35276

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.

FDA product code: KZI — Culture Media, Enriched
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Lot #435902, Exp. 2004-11-04

Why it was recalled

The product does not perform as intended with some quality control organisms (Haemophilus influenzae)

Root cause (FDA determination)

Other

Action the firm took

The recalling firm notified their customers via telephone on 9/27/04 requesting they examine their inventory and discard the recalled lot.

Recalling firm

Firm: Remel, Inc.
Address: 12076 Santa Fe Trail Dr (PO Box 14478, zip 66285-4478), Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Distribution was made to medical facilities and laboratories located in IA, KS, MO, FL, NY, IL, AR, TX, and OK.

Timeline

Recall initiated: 2004-09-27
Posted by FDA: 2004-10-20
Terminated: 2006-04-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35276. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.