Recall Z-1287-2019— Ortho-Clinical Diagnostics

Name: FDA recall Z-1287-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-20

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2019-02-20, terminated 2021-09-15. It names one FDA 510(k) clearance: K081543. Product: VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. Reason: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems.

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2019-02-20
Terminated: 2021-09-15
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 -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

Reason for recall

Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems

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