ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.
FDA Recall Z-1376-04 · Posted 2004-08-17
Recalling FirmRemel, Inc.
Recall StatusTerminated
Product CodeMHJ
Date Initiated2002-05-09
Date Terminated2004-09-15
Product Quantity388 kits (187 - 910717, 201 - 912101)
Reason for Recall
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.
Firm Action
A potential stability problem has been identified with the positive control in the ProSpecT CryptoSporidium Microplate Assay. The positive control may not perform as intended through its expiration date and may invalidate an otherwise acceptable run.
Root Cause
Other
Distribution Pattern
in the US
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.