Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box.
- Company
- Meridian Bioscience Inc
- Recall Initiated
- December 26, 2002
- Posted
- January 23, 2003
- Terminated
- March 29, 2004
- Recall Number
- Z-0463-03
- Quantity
- 1,215 kits
- Firm Location
- Cincinnati, OH
Reason for Recall
Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
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.
Lot / Code Info
Lot #601096.180, Exp Date 27 SEP 03; Kit Catalog #601096.
Root Cause
Other
Action Taken
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.