Z-1373-04

ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well...

Name: Z-1373-04 ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well...
Creator: Remel, Inc.
Published: 2002-07-18
License: https://open.fda.gov/license/

Remel Inc / initiated 2002-07-18 / Terminated

FDA source

Remel, Inc. began a recall of ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins... on 2002-07-18. The reason FDA records is "A potential contamination was noted in the conjugate in the ProSpecT Shiga Toxin E. coli Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1373-04
Status: Terminated
Initiated: 2002-07-18
Posted: 2004-08-17
Terminated: 2004-09-15
Recalling firm: Remel Inc
Product: ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures.
Product code: GMZ Antigens, All Types, Escherichia Coli
Reason for recall: A potential contamination was noted in the conjugate in the ProSpecT Shiga Toxin E. coli Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
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: 83 (15-2474048, 68-2474096)
Distribution: US and OUS.
Product codes and lots: 918706 918707

Product code GMZ

K980507Class IProspect Shiga Toxin Microplate AssayAlexon - Trend, Inc. / cleared 1998-04-23

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)