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U.S. Department of Health and Human Services

Class 3 Device Recall IgM Conjugate

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  Class 3 Device Recall IgM Conjugate see related information
Date Initiated by Firm January 23, 2013
Date Posted June 05, 2013
Recall Status1 Terminated 3 on May 05, 2015
Recall Number Z-1478-2013
Recall Event ID 64164
510(K)Number K880679  
Product Classification Antigen, cf (including cf control), cytomegalovirus - Product Code GQH
Product Plastic bottle containing 10.5 mL of IgM Conjugate

Product Usage:
Product is a used as a counterstain for various indirect fluorescent assay kits
Code Information Product Code: CCM-9914;   Lot: CCM-0281
Recalling Firm/
Manufacturer		 Bion Enterprises Ltd
455 State St
Suite 100
Des Plaines IL 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		 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 201 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 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) Database 510(K)s with Product Code = GQH and Original Applicant = BION ENT., LTD.
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