Z-1203-06

ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A...

Name: Z-1203-06 ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A...
Creator: Meridian Bioscience Inc
Published: 2006-06-02
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2006-06-02 / Terminated

FDA source

Meridian Bioscience Inc began a recall of ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An... on 2006-06-02. The reason FDA records is "The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity rates". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1203-06
Status: Terminated
Initiated: 2006-06-02
Posted: 2006-07-04
Terminated: 2012-02-16
Recalling firm: Meridian Bioscience Inc
Product: ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An in vitro diagnostic.
Product code: LLH Reagents, Clostridium Difficile Toxin
Reason for recall: The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity rates.
FDA root cause: Other
Action: The recalling firm sent a recall letter dated 6/2/06 to their customers.
Quantity in commerce: 704
Distribution: Nationwide.
Product codes and lots: Lot 712050.066, expiration date 2007-02-22 and Lot 712050.068, expiration date 2007-03-08.

Product code LLH

K041003Class IImmunocard Toxins a & B, Model 712050Meridian Bioscience, Inc. / cleared 2004-08-20

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)