—#34313

Product

ProSpecT Campylobacter Microplate Assay. Catalog #2476096.

FDA product code: LQP — Campylobacter Spp.
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K982315
Affected lot / code info: Lot #910718

Why it was recalled

A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.

Root cause (FDA determination)

Other

Action the firm took

Remel contacted the customer with a letter, requesting a count of the affected lot, and offered replacement of the kits.

Recalling firm

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

Distribution

Distribution pattern: Entire lot was shipped to one customer in Russelsheim, Germany.

Timeline

Recall initiated: 2002-07-15
Posted by FDA: 2004-08-17
Terminated: 2006-12-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34313. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.