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U.S. Department of Health and Human Services

Class 3 Device Recall Quidel MicroVue Intact PTH EIA, Model 8044

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  Class 3 Device Recall Quidel MicroVue Intact PTH EIA, Model 8044 see related information
Date Initiated by Firm October 26, 2016
Create Date April 25, 2018
Recall Status1 Terminated 3 on August 28, 2020
Recall Number Z-1520-2018
Recall Event ID 79595
510(K)Number K974306  
Product Classification Radioimmunoassay, parathyroid hormone - Product Code CEW
Product Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Code Information Lot 068259
Recalling Firm/
Manufacturer		 Diagnostic Hybrids, Inc.
2005 E State St Ste 100
Athens OH 45701-2125
For Additional Information Contact Ronald H. Lollar
740-589-3373
Manufacturer Reason
for Recall		 There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Customers were notified via letter and email on 10/26/16. Customers were asked to complete and return the attached response form to the recalling firm. Customers were asked to review inventory, quarantine the products with the specified lot numbers, and, if further distributed, identify and notify any additional customers.
Quantity in Commerce 26
Distribution The product was distributed to the following countries: Singapore, 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 = CEW and Original Applicant = SANGUI BIOTECH, INC.
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