VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
FDA Recall Z-0061-2019 · Posted None
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Recalling FirmOrtho Clinical Diagnostics Inc
Recall StatusOpen, Classified
Product CodeJLW
Date Initiated2018-07-12
Product Quantity68230
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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