Z-0062-04

Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096

Name: Z-0062-04 Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096
Creator: Meridian Bioscience Inc
Published: 2003-09-23
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2003-09-23 / Terminated / root cause: packaging

FDA source

Meridian Bioscience Inc began a recall of Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096 on 2003-09-23. The reason FDA records is "The kits were packaged with incorrect dispensing pipettes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0062-04
Status: Terminated
Initiated: 2003-09-23
Posted: 2003-10-24
Terminated: 2004-03-29
Recalling firm: Meridian Bioscience Inc
Product: Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096.
Product code: LLH Reagents, Clostridium Difficile Toxin
Reason for recall: The kits were packaged with incorrect dispensing pipettes.
Root cause tag: packaging
FDA root cause: Other
Action: The firm notified their affected consignees by letter on 9/23/2003.
Quantity in commerce: 2030 kits
Distribution: The kits were shipped to consignees located nationwide, and into New Zealand, Haiti, Belgium, Italy, Brazil, Australia, Canada, and Chile.
Product codes and lots: Lots 616096.095, -096, and -097. Expiration Date: 23 Jul 03.

Product code LLH

K993914Class IPremier Toxins A&b, Model 616096Meridian Diagnostics, Inc. / cleared 1999-12-10

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)