FDA-Device2018-10-10Class II
VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
Ortho Clinical Diagnostics Inc
Hazard
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.
Sold states
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.
Affected count
68230
Manufactured in
1001 US Highway 202, Raritan, NJ, United States
Products
VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0061-2019Don't want to check this manually?
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