VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
Reported: October 10, 2018 Initiated: July 12, 2018 #Z-0060-2019
Product Description
VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
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.
Details
- Recalling Firm
- Ortho Clinical Diagnostics Inc
- Units Affected
- 1790
- 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.
- Location
- Raritan, NJ
Frequently Asked Questions
What product was recalled? ▼
VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793. Recalled by Ortho Clinical Diagnostics Inc. Units affected: 1790.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 10, 2018. Severity: Moderate. Recall number: Z-0060-2019.
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