| Class 3 Device Recall MicroVue CICC1q EIA |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DAK
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