Home / Recalls / Ortho Clinical Diagnostics / Z-2771-2020

Z-2771-2020 Class II Terminated

Recalled by Ortho Clinical Diagnostics — Rochester, NY

Recall Details

Product Type
Devices
Report Date
August 19, 2020
Initiation Date
July 17, 2020
Termination Date
July 16, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2349 sales units

Product Description

VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.

Reason for Recall

The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.

Distribution Pattern

Worldwide distribution - US Nationwide distribution.

Code Information

Lots 0010 - 0013

Other recalls by Ortho Clinical Diagnostics

  • Z-0120-2022 Class II — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD) (September 10, 2021)
  • Z-0844-2021 Class II — VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentratio (December 15, 2020)
  • Z-0845-2021 Class II — VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitat (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-0451-2021 Class II — VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: F (September 30, 2020)
  • Z-2879-2020 Class II — VITROS XT7600 Integrated System, Product code 6844461 (July 20, 2020)
  • Z-2878-2020 Class II — VITROS XT3400 Chemistry System, Product code 6844458 (July 20, 2020)
  • Z-2770-2020 Class II — VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199 (July 17, 2020)