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U.S. Department of Health and Human Services

Class 3 Device Recall MicroVue CICC1q EIA

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  Class 3 Device Recall MicroVue CICC1q EIA see related information
Date Initiated by Firm November 03, 2015
Create Date April 24, 2018
Recall Status1 Terminated 3 on August 28, 2020
Recall Number Z-1497-2018
Recall Event ID 79642
510(K)Number K862649  
Product Classification Complement c1q, antigen, antiserum, control - Product Code DAK
Product MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma.

The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.
Code Information Lot 051076
Recalling Firm/
Manufacturer		 Diagnostic Hybrids, Inc.
2005 E State St Ste 100
Athens OH 45701-2125
For Additional Information Contact Ronald H. Lollar
740-589-3300
Manufacturer Reason
for Recall		 A component of the kit was found to contain bacterial contamination.
FDA Determined
Cause 2		 Material/Component Contamination
Action Customers were notified via letter dated November 3, 2015, to review their inventory for the specified lots, discard the kits, and contact the recalling firm for replacement. Certificates of destruction were also provided to customers. For further questions, please call (740) 589-3300.
Quantity in Commerce 19 kits
Distribution Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.
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 = DAK and Original Applicant = CYTOTECH, INC.
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