Ortho Clinical Diagnostics Inc: Medical Device Recall in 2018 - (Recall #: Z-0058-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266

Product Classification:

Class II

Date Initiated: July 12, 2018

Date Posted: October 10, 2018

Recall Number: Z-0058-2019

Event ID: 80717

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.

Status: Ongoing

Product Quantity: 7880

Code Information:

2470 2480 2490 2501 2510 2521

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.

Voluntary or Mandated:

Voluntary: Firm initiated