FDAFDA · Food and drugs·Recall number Z-0058-2019
VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Published October 10, 2018 · Recall initiated: July 12, 2018
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ortho Clinical Diagnostics Inc
- Distributor
- 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.
- Lot
- 2470 2480 2490 2501 2510 2521
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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