Z-1376-04

ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096

Name: Z-1376-04 ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096
Creator: Remel, Inc.
Published: 2002-05-09
License: https://open.fda.gov/license/

Remel Inc / initiated 2002-05-09 / Terminated

FDA source

Remel, Inc. began a recall of ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096 on 2002-05-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1376-04
Status: Terminated
Initiated: 2002-05-09
Posted: 2004-08-17
Terminated: 2004-09-15
Recalling firm: Remel Inc
Product: ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.
Product code: MHJ Cryptosporidium Spp.
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.
FDA root cause: Other
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.
Quantity in commerce: 388 kits (187 - 910717, 201 - 912101)
Distribution: in the US
Product codes and lots: 910717 912101

Product code MHJ

K031965Class IIXpect Cryptosporidium Lateral Flow Assay, Model 2451020Remel, Inc. / cleared 2003-11-14

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)