Z-0059-2019 Class II Ongoing
FDA device recall Z-0059-2019 was initiated by Ortho Clinical Diagnostics Inc on Jul 12, 2018 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1955.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 10, 2018
- Initiation Date
- Jul 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1955
Product Description
VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
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.
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.
Code Information
2470 2480 2490 2500 2510 2520 2530
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0059-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026