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U.S. Department of Health and Human Services

Class 2 Device Recall Premier Platinum HpSA

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 Class 2 Device Recall Premier Platinum HpSAsee related information
Date Initiated by FirmDecember 26, 2002
Date PostedJanuary 23, 2003
Recall Status1 Terminated 3 on March 29, 2004
Recall NumberZ-0465-03
Recall Event ID 25295
510(K)NumberK983255 
Product Classification Helicobacter Pylori - Product Code LYR
ProductPremier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box.
Code Information Lot #601348.069, Exp Date 22 SEP 03; Lot #601348.070, Exp Date 22 SEP 03;  Kit Catalog #601348
Recalling Firm/
Manufacturer		 Meridian Bioscience Inc
3471 River Hills Dr
Cincinnati OH 45244
Manufacturer Reason
for Recall		Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce1,020 kits
DistributionThe 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LYR
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