Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1367-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960

Product Classification:

Class II

Date Initiated: May 26, 2022

Date Posted: July 20, 2022

Recall Number: Z-1367-2022

Event ID: 90408

Reason for Recall:

On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).

Status: Ongoing

Product Quantity: 20858

Code Information:

UDI-DI :10758750034413. All expired, in-date and future released lots

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated