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Terminated

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

FDA Recall Z-1375-04 · Posted 2004-08-17

Recalling FirmRemel, Inc.
Recall StatusTerminated
Product CodeMHI
Date Initiated2003-12-09
Date Terminated2004-09-15
Product Quantity127 kits

Reason for Recall

The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.

Firm Action

Remel contacted each customer with a letter, by mail, requesting a count of the affected lots to be returned. Product would be replaced upon customer request.

Root Cause

Other

Distribution Pattern

US and OUS customers.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955157PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAYAlexon Biomedical, Inc. · 1996-02-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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