Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1396-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976

Product Classification:

Class II

Date Initiated: March 9, 2023

Date Posted: April 26, 2023

Recall Number: Z-1396-2023

Event ID: 92017

Reason for Recall:

Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results

Status: Ongoing

Product Quantity: 256 units

Code Information:

UDI: 10758750034581 Lot # /Expiration Date: 0230 22-Feb-2023; 0240 22-Mar-2023; 0250 26-Apr-2023.

Distribution Pattern:

US Nationwide distribution in the states of AL, AZ, CA, GA, NY.

Voluntary or Mandated:

Voluntary: Firm initiated