Home / Recalls / Ortho Clinical Diagnostics / Z-2183-2019

Z-2183-2019 Class II Terminated

Recalled by Ortho Clinical Diagnostics — Rochester, NY

Recall Details

Product Type
Devices
Report Date
August 14, 2019
Initiation Date
July 8, 2019
Termination Date
October 19, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1051

Product Description

VITROS 5,1 FS Chemistry System, clinical chemistry analyzer

Reason for Recall

Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Distribution Pattern

Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.

Code Information

product code: 6801375 UDI: 10758750001132 Affected software : Version 3.1 or above

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-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-2771-2020 Class II — VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6 (July 17, 2020)