Home / Recalls / Ortho Clinical Diagnostics Inc / Z-0451-2021

Z-0451-2021 Class II Terminated

Recalled by Ortho Clinical Diagnostics Inc — Raritan, NJ

Recall Details

Product Type
Devices
Report Date
November 25, 2020
Initiation Date
September 30, 2020
Termination Date
December 7, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
691 units (OUS)

Product Description

VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier): 6199921 (10758750033355)

Reason for Recall

Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.

Code Information

Lot Number/ Exp. Date: 0110 25-NOV-20

Other recalls by Ortho Clinical Diagnostics Inc

  • Z-0120-2022 Class II — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD) (September 10, 2021)
  • Z-0845-2021 Class II — VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitat (December 15, 2020)
  • Z-0844-2021 Class II — VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentratio (December 15, 2020)
  • Z-0770-2021 Class II — VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartri (December 11, 2020)
  • Z-0471-2021 Class III — VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use on (October 16, 2020)
  • Z-0450-2021 Class II — VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-V (September 30, 2020)
  • Z-2878-2020 Class II — VITROS XT3400 Chemistry System, Product code 6844458 (July 20, 2020)
  • Z-2879-2020 Class II — VITROS XT7600 Integrated System, Product code 6844461 (July 20, 2020)
  • Z-2770-2020 Class II — VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199 (July 17, 2020)
  • Z-2771-2020 Class II — VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6 (July 17, 2020)