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U.S. Department of Health and Human Services

Class 2 Device Recall Histoplasma Yeast Complement Fixation Antigen Dilute

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  Class 2 Device Recall Histoplasma Yeast Complement Fixation Antigen Dilute see related information
Date Initiated by Firm May 09, 2016
Date Posted June 20, 2016
Recall Status1 Terminated 3 on January 10, 2017
Recall Number Z-2040-2016
Recall Event ID 74113
510(K)Number K791393  
Product Classification Antigens, histoplasma capsulatum, all - Product Code GMJ
Product Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150
The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
Code Information Lot 111WH3
Recalling Firm/
Manufacturer		 Immuno-Mycologics, Inc
2700 Technology Pl
Norman OK 73071-1127
Manufacturer Reason
for Recall		 The device was found to have bacterial contamination.
FDA Determined
Cause 2		 Process control
Action Immuno-Mycologics, Inc sent an Urgent Medical Device Recall letter dated May 9, 2016, to all affected customers. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their stock and destroy affected stock on hand. Immediately complete the attached Acknowledgement and Receipt Form even if they do not have affected stock. Customers who require replacement indicate the number of vials needed in the attached Acknowledgement Form. Customers with questions were instructed to call 1-405-360-4669.
Quantity in Commerce 467 units
Distribution Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
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 = GMJ and Original Applicant = IMMUNO-MYCOLOGICS, INC.
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