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U.S. Department of Health and Human Services

Class 2 Device Recall Premier CMV IgG Elisa Kits

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 Class 2 Device Recall Premier CMV IgG Elisa Kitssee related information
Date Initiated by FirmJune 18, 2003
Date PostedAugust 12, 2003
Recall Status1 Terminated 3 on March 29, 2004
Recall NumberZ-1127-03
Recall Event ID 26505
510(K)NumberK924096 
Product Classification Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus - Product Code LFZ
ProductPremier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.
Code Information Lot Numbers: #03022371 and #03022472. All lots Exp Date: 2004-07. 
FEI Number 1524213
Recalling Firm/
Manufacturer		 Meridian Bioscience Inc
3471 River Hills Dr
Cincinnati OH 45244
For Additional Information Contact
513-271-3700
Manufacturer Reason
for Recall		The Low Positive Standard kit component is losing potency that may result in false positive test results.
FDA Determined
Cause 2		Other
ActionThe firm notified their customers by telephone and fax on 6/18/2003.
Quantity in Commerce43 kits
DistributionThe kits were shipped to end-users located in CA, UT, NY, MD, KY; and to a foreign distributor in Belgium.
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 = LFZ
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