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Class 2 Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
July 12, 2018 |
Create Date |
October 03, 2018 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0061-2019 |
Recall Event ID |
80717 |
510(K)Number |
K081543
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Product Classification |
Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
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Product |
VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
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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
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For Additional Information Contact |
Mr. Joe Falvo 585-453-3452
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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.
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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 |
68230 |
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
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = JLW and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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