ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496.
FDA Recall Z-1374-04 · Posted 2004-08-17
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Recalling FirmRemel, Inc.
Recall StatusTerminated
Product CodeMHI
Date Initiated2002-11-21
Date Terminated2004-09-15
Product Quantity12
Reason for Recall
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
US only
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.
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