Recall Z-0848-2019— Ortho-Clinical Diagnostics

Name: FDA recall Z-0848-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-11

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2018-12-11, terminated 2020-09-16. It names one FDA 510(k) clearance: K042476. Product: VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.. Reason: Negative bias results when using VITROS VALP Reagent, GEN 25..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2018-12-11
Terminated: 2020-09-16
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K042476 — VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOSOrtho-Clinical Diagnostics, Inc.·cleared 2004-12-01

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 VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.

Reason for recall

Negative bias results when using VITROS VALP Reagent, GEN 25.

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