Z-0463-03

Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box

Name: Z-0463-03 Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box
Creator: Meridian Bioscience Inc
Published: 2002-12-26
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2002-12-26 / Terminated / root cause: labeling and UDI

FDA source

Meridian Bioscience Inc began a recall of Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box on 2002-12-26. The reason FDA records is "Due to defective packaging, the firm cannot assure product stability through the labeled expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0463-03
Status: Terminated
Initiated: 2002-12-26
Posted: 2003-01-23
Terminated: 2004-03-29
Recalling firm: Meridian Bioscience Inc
Product: Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box.
Product code: MCB Antigen, C. Difficile
Reason for recall: Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm mailed notices to their affected customers on 12/26/2002. The consignees were instructed to visually and physically inspect the seals on each microwell pouch for gaps. If properly sealed, the use of the microwells may be continued. Test wells in pouches with defective seals are to be quarantined and destroyed. The customers are asked to report back to the firm. All test microwell plates in defective pouches will be replaced by the firm.
Quantity in commerce: 1,215 kits
Distribution: The kits were distributed to end-users and distributors located nationwide; and to foreign distributors located in China, Guatemala, New Zealand, Hong Kong, Mexico, Great Britain, Belgium, Italy, Brazil, Australia, Canada, Thailand, Honduras, and Japan.
Product codes and lots: Lot #601096.180, Exp Date 27 SEP 03; Kit Catalog #601096.

Product code MCB

K926442Class IPremier C. Difficile, ModificationMeridian Diagnostics, Inc. / cleared 1993-01-27

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)