Z-1372-04

ProSpecT Campylobacter Microplate Assay. Catalog #2476096

Name: Z-1372-04 ProSpecT Campylobacter Microplate Assay. Catalog #2476096
Creator: Remel, Inc.
Published: 2002-07-15
License: https://open.fda.gov/license/

Remel Inc / initiated 2002-07-15 / Terminated

FDA source

Remel, Inc. began a recall of ProSpecT Campylobacter Microplate Assay. Catalog #2476096 on 2002-07-15. The reason FDA records is "A potential contamination was noted in the conjugate in ProSpecT Campylobacter 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-1372-04
Status: Terminated
Initiated: 2002-07-15
Posted: 2004-08-17
Terminated: 2006-12-28
Recalling firm: Remel Inc
Product: ProSpecT Campylobacter Microplate Assay. Catalog #2476096.
Product code: LQP Campylobacter Spp.
Reason for recall: A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
FDA root cause: Other
Action: Remel contacted the customer with a letter, requesting a count of the affected lot, and offered replacement of the kits.
Quantity in commerce: 382
Distribution: Entire lot was shipped to one customer in Russelsheim, Germany.
Product codes and lots: Lot #910718

Product code LQP

K982315Class IProspect Campylobacter Microplate AssayAlexon - Trend, Inc. / cleared 1998-11-18

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)