Recall Z-2182-2019— Ortho Clinical Diagnostics

Name: FDA recall Z-2182-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-08

Class II · Terminated

Class II FDA medical device recall by Ortho Clinical Diagnostics, initiated 2019-07-08, terminated 2023-10-19. It names one FDA 510(k) clearance: K063144. Product: VITROS 4600 Chemistry System, clinical chemistry analyzer. Reason: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System.

Recalling firm: Ortho Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2019-07-08
Terminated: 2023-10-19
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K063144 — VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEMOrtho-Clinical Diagnostics, Inc.·cleared 2006-11-13

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 4600 Chemistry System, clinical chemistry analyzer

Reason for recall

Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

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