Z-1375-04

ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496

Name: Z-1375-04 ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496
Creator: Remel, Inc.
Published: 2003-12-09
License: https://open.fda.gov/license/

Remel Inc / initiated 2003-12-09 / Terminated

FDA source

Remel, Inc. began a recall of ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496 on 2003-12-09. The reason FDA records is "The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1375-04
Status: Terminated
Initiated: 2003-12-09
Posted: 2004-08-17
Terminated: 2004-09-15
Recalling firm: Remel Inc
Product: ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496.
Product code: MHI Giardia Spp.
Reason for recall: The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.
FDA root cause: Other
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.
Quantity in commerce: 127 kits
Distribution: US and OUS customers.
Product codes and lots: 944755

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)