Z-1374-04

ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496

Name: Z-1374-04 ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496
Creator: Remel, Inc.
Published: 2002-11-21
License: https://open.fda.gov/license/

Remel Inc / initiated 2002-11-21 / Terminated

FDA source

Remel, Inc. began a recall of ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496 on 2002-11-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1374-04
Status: Terminated
Initiated: 2002-11-21
Posted: 2004-08-17
Terminated: 2004-09-15
Recalling firm: Remel Inc
Product: ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496.
Product code: MHI Giardia Spp.
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.
FDA root cause: Other
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.
Quantity in commerce: 12
Distribution: US only
Product codes and lots: 926230

Product code MHI

K955157Class IIProspect Giardia/cryptosporidium Microplate AssayAlexon Biomedical, Inc. / cleared 1996-02-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)