Recall Z-0817-2014— Ortho-Clinical Diagnostics

Name: FDA recall Z-0817-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-04

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2013-10-04, terminated 2018-05-17. It names one FDA 510(k) clearance: K062123. Product: VITROS Chemistry Products COCM Reagent. Reason: Inaccurate quality control results..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2013-10-04
Terminated: 2018-05-17
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K062123 — VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IVOrtho-Clinical Diagnostics, Inc.·cleared 2006-11-16

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 Chemistry Products COCM Reagent

Reason for recall

Inaccurate quality control results.

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