Recall Z-0650-2019— Ortho-Clinical Diagnostics

Name: FDA recall Z-0650-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-19

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2018-10-19, terminated 2022-01-24. It names one FDA 510(k) clearance: K081543. Product: VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.. Reason: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2018-10-19
Terminated: 2022-01-24
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K081543 — VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEMOrtho-Clinical Diagnostics, Inc.·cleared 2008-10-23

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 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

Reason for recall

Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

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