Home / Recalls / Ortho Clinical Diagnostics / Z-2482-2020

Z-2482-2020 Class II Terminated

Recalled by Ortho Clinical Diagnostics — Rochester, NY

Recall Details

Product Type
Devices
Report Date
July 8, 2020
Initiation Date
May 20, 2020
Termination Date
November 16, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2617 units (U.S.=1272; OUS=1344)

Product Description

VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740

Reason for Recall

Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances

Distribution Pattern

US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN

Code Information

Affected Serial Number Range : J56000114- J56001879

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-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-2770-2020 Class II — VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199 (July 17, 2020)