Ortho Clinical Diagnostics Inc: Medical Device Recall in 2018 - (Recall #: Z-0061-2019)

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 - TSH Reagent Pack (10758750000227) 1912997

Product Classification:

Class II

Date Initiated: July 12, 2018

Date Posted: October 10, 2018

Recall Number: Z-0061-2019

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: 68230

Code Information:

5535 5540 5550 5560 5570 5580 5590 5600 5610 5615 5620 5630 5640 5650 5655 5660 5665 5670 5675 5678 5680 5685 5690

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