Recall Z-0059-2019— Ortho Clinical Diagnostics Inc

Name: FDA recall Z-0059-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-12

Class II · Ongoing

Class II FDA medical device recall by Ortho Clinical Diagnostics Inc, initiated 2018-07-12. It names one FDA 510(k) clearance: K964720. Product: VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922. Reason: 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..

Recalling firm: Ortho Clinical Diagnostics Inc
Classification: Class II
Status: Ongoing
Initiated: 2018-07-12
Firm location: Raritan, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K964720 — VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)Johnson & Johnson Clinical Diagnostics, Inc.·cleared 1997-02-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.