Ortho Clinical Diagnostics Inc: Medical Device Recall in 2020 - (Recall #: Z-0450-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)

Product Classification:

Class II

Date Initiated: September 30, 2020

Date Posted: November 25, 2020

Recall Number: Z-0450-2021

Event ID: 86573

Reason for Recall:

Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control

Status: Terminated

Product Quantity: 651 units

Code Information:

Lot Number/ Exp. Date: 0165 24-NOV-20 0180 19-NOV-20 0185 27-NOV-20 0190 21-NOV-20 0200 23-NOV-20 0205 27-NOV-20 0220 03-DEC-20 0230 03-DEC-20

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.

Voluntary or Mandated:

Voluntary: Firm initiated