Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box.
FDA Recall Z-0463-03 · Posted 2003-01-23
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Recalling FirmMeridian Bioscience Inc
Recall StatusTerminated
Product CodeMCB
Date Initiated2002-12-26
Date Terminated2004-03-29
Product Quantity1,215 kits
Reason for Recall
Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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