Recall Z-0471-2021— Ortho Clinical Diagnostics Inc

Name: FDA recall Z-0471-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-16

Class III · Ongoing

Class III FDA medical device recall by Ortho Clinical Diagnostics Inc, initiated 2020-10-16. It names one FDA 510(k) clearance: K904768. Product: VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474. Reason: Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures.

Recalling firm: Ortho Clinical Diagnostics Inc
Classification: Class III
Status: Ongoing
Initiated: 2020-10-16
Firm location: Raritan, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K904768 — KODATROL I AND II CONTROL AND DILUENT SETEastman Kodak Company·cleared 1990-11-09

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 Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

Reason for recall

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

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