Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall VITROS Immunodiagnostic Products TSH Reagent Packsee related information
Date Initiated by FirmJuly 12, 2018
Create DateOctober 03, 2018
Recall Status1 Open3, Classified
Recall NumberZ-0061-2019
Recall Event ID 80717
510(K)NumberK081543 
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
ProductVITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
Code Information 5535 5540 5550 5560 5570 5580 5590 5600 5610 5615 5620 5630 5640 5650 5655 5660 5665 5670 5675 5678 5680 5685 5690 
Recalling Firm/
Manufacturer		 Ortho Clinical Diagnostics Inc
1001 US Highway 202
Raritan NJ 08869-1424
For Additional Information ContactMr. 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
ActionOn 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 Commerce68230
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = JLW
-
-