Home / Recalls / Ortho Clinical Diagnostics / Z-2878-2020

Z-2878-2020 Class II Terminated

Recalled by Ortho Clinical Diagnostics — Rochester, NY

Recall Details

Product Type
Devices
Report Date
September 2, 2020
Initiation Date
July 20, 2020
Termination Date
December 18, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
pending

Product Description

VITROS XT3400 Chemistry System, Product code 6844458

Reason for Recall

When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.

Code Information

Serial numbers J34500122 J34500231

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-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-0451-2021 Class II — VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: F (September 30, 2020)
  • Z-0450-2021 Class II — VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-V (September 30, 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)