MHJClass II

Cryptosporidium Spp.

Microbiology · 21 CFR 866.3220

MDR events5All time

Recalls1All time

Registered firms28Currently listed

510(k) clearances15All time

Recent MDR events

5 adverse event reports on file

Event type breakdown

Malfunction4

Other1

Most-reported manufacturers

*2 Alexon-trend1 Becton Dickinson1 Genzyme Corp.1

Recalls

1 recall events for this product code

Remel, Inc.
TerminatedAug 17, 2004
ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.
A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may NOT perform as intended through its expiration date and may invalidate an otherwise acceptable run. Quality control testing indicates the other reagents in these kits are performing as intended.
Z-1376-04 · View FDA record ↗

Registered firms

28 firms currently registered for this product code

510(k) clearances

15 clearances for this product code