Recall Z-1293-2019— Ortho-Clinical Diagnostics

Name: FDA recall Z-1293-2019
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: K962919. Product: VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 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

K962919 — VITROS IMMUNODIAGNOSTIC SYSTEMJohnson & Johnson Clinical Diagnostics, Inc.·cleared 1996-10-18

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 ECi Immunodiagnostic System Refurbished Product Code: 6801059 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.