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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic Products Prolactin Reagent Pack

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  Class 2 Device Recall VITROS Immunodiagnostic Products Prolactin Reagent Pack see related information
Date Initiated by Firm July 12, 2018
Create Date October 03, 2018
Recall Status1 Open3, Classified
Recall Number Z-0060-2019
Recall Event ID 80717
510(K)Number K970281  
Product Classification Radioimmunoassay, prolactin (lactogen) - Product Code CFT
Product VITROS Immunodiagnostic Products - Prolactin Reagent Pack
(10758750000111) 1849793
Code Information 2330 2340 2350 2360 2370 2380 
Recalling Firm/
Manufacturer		 Ortho Clinical Diagnostics Inc
1001 US Highway 202
Raritan NJ 08869-1424
For Additional Information Contact Mr. Joe Falvo
585-453-3452
Manufacturer Reason
for Recall		 The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.
FDA Determined
Cause 2		 Device Design
Action On 12 July 2018, a customer letter was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail to all customers who could process the affected products (i.e., VITROS 3600, 5600 and/or ECi/ECiQ Systems) to inform them of the potential interference of biotin at levels lower than stated in the IFUs and that Ortho is in the process of revising the IFUs for the affected products. Ortho recommended customers follow normal laboratory procedures for troubleshooting of samples containing other assay interferences and it was acceptable to continue using the affected products. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce 1790
Distribution Worldwide Distribution - US Nationwide distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and Netherlands.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CFT and Original Applicant = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
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