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U.S. Department of Health and Human Services

Class 3 Device Recall IgG FITC Conjugate

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 Class 3 Recall
IgG FITC Conjugate
see related information
Date Posted June 05, 2013
Recall Status1 Open
Recall Number Z-1479-2013
Recall Event ID 64164
Premarket Notification
510(K) Number
K926066 
Product Classification Enzyme Linked Immunoabsorbent Assay, Mumps Virus - Product Code LJY
Product Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
Code Information Product Code: CCG-9972; Lot: CCG-0281
Recalling Firm/
Manufacturer
Bion Enterprises Ltd
455 State St
Suite 100
Des Plaines, Illinois 60016-2204
For Additional Information Contact Judy Rasmussen
847-544-5044
Manufacturer Reason
for Recall
Affected products have a labeled expiration date of one year too long.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action MBL Bion sent an Urgent Product Recall letter dated January 28, 2013 to all affected customers via email. The letter identified the affected product, problem and actions to be taken. Customers were requested to destroy the affected product and to notify Bion of the number of units consumed and destroyed. For questions call 847-544-5044.
Quantity in Commerce 504 units
Distribution Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LJY and Original Applicant = BION ENT., LTD.
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