—#34335

Product

ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496.

FDA product code: MHI — Giardia Spp.
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K955157
Affected lot / code info: 926230

Why it was recalled

The conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause the dropper tips to become plugged. Quality control testing indicated that the reagents were still performing as intended, including the conjugates.

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

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

Distribution

Distribution pattern: US only

Timeline

Recall initiated: 2002-11-21
Posted by FDA: 2004-08-17
Terminated: 2004-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34335. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.