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U.S. Department of Health and Human Services

Class 2 Device Recall MicroVue CICC1q EIA

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  Class 2 Device Recall MicroVue CICC1q EIA see related information
Date Initiated by Firm April 04, 2017
Create Date April 24, 2018
Recall Status1 Terminated 3 on August 28, 2020
Recall Number Z-1496-2018
Recall Event ID 79629
510(K)Number K862649  
Product Classification Complement c1q, antigen, antiserum, control - Product Code DAK
Product MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma.
The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (¿g Eq/ml) can be determined by comparison to a standard curve.
Code Information Lot 084007
Recalling Firm/
Manufacturer		 Diagnostic Hybrids, Inc.
2005 E State St Ste 100
Athens OH 45701-2125
For Additional Information Contact Ronald H. Lollar
740-859-3300
Manufacturer Reason
for Recall		 There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
FDA Determined
Cause 2		 Other
Action Customers were notified via letter on 4/4/17. Customers were asked to review their current inventory for the specified lot and complete and return the response form. If the product was further distributed, customers were instructed to provide them with the notification letter.
Quantity in Commerce 101 kits
Distribution The products were distributed to the following US states: NY, TX, CO, UT. The products were distributed to the following foreign countries: Switzerland.
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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