The Recall Desk
ModerateFDA (Devices)·Z-1396-2023·Announced 2023-04-26

VITROS COVID-19 Antibody Test Calibrators Recalled for Incorrect Calibrator Levels

Ortho-Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total N Antibody Calibrators used in COVID-19 testing due to incorrect calibrator levels in Assay Data Disks, which can delay patient test results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported hospitalizations or patient injuries. The primary hazard is an operational issue—incorrect calibrator levels causing delayed diagnostic results. The severity rubric indicates recalls with no reported illnesses and operational hazards score at most 3, and this functional defect without reported harm justifies a Moderate (2) classification.

Plain-English summary

Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators, which are used to calibrate COVID-19 antibody testing machines. The recalled products include Assay Data Disks (ADD) versions 6213 through 6218 that contain an incorrect number of calibrator levels, which can result in delayed patient test results.

The affected products were distributed nationwide to facilities in Alabama, Arizona, California, Georgia, and New York. The recalled lot numbers are 0230 (expiration 22-Feb-2023), 0240 (expiration 22-Mar-2023), and 0250 (expiration 26-Apr-2023), totaling 256 units. The product code is 6199976 with UDI 10758750034581.

Facilities using affected calibrators should contact Ortho-Clinical Diagnostics for replacement products or additional guidance.

The recalled product

Product
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
Manufacturer
Ortho-Clinical Diagnostics, Inc.
Category
Medical Device — Diagnostic Test Calibrators
Hazard
Affected units
256

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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