Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0450-2021·Announced 2020-11-25

Ortho Recalls VITROS SARS-CoV-2 IgG Calibrators Due to Elevated Signal Values

Ortho Clinical Diagnostics is recalling specific lots of VITROS SARS-CoV-2 IgG Calibrators because they produced elevated signal values. The recall also includes one lot of IgG Controls with decreased signal.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: The recall is classified as FDA Class II. The source text describes a performance issue (elevated/decreased signal values) but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving potential mislabeling or performance defects without reported harm.

Plain-English summary

Ortho Clinical Diagnostics Inc is recalling 651 units of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrators and one lot of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls. The recall is due to elevated sample results signal/cutoff (s/c) values observed in eight lots of the Calibrator and decreased signal in one lot of the Control.

The affected products are In-Vitro Diagnostics (EUA) used as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The recall covers specific lot numbers and expiration dates, including 0165, 0180, 0185, 0190, 0200, 0205, 0220, and 0230. The products were distributed worldwide, including in the United States, Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore, the United Kingdom, and Italy.

Authorized laboratories should stop using the affected lots and contact Ortho Clinical Diagnostics for further instructions. This recall is classified as Class II by the FDA.

The recalled product

Product: 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…
Manufacturer: Ortho Clinical Diagnostics Inc
Category: Medical Device — In-Vitro Diagnostic
Hazard: performance-defect
mis-labeling
Affected units: 651

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Ortho Clinical Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Ortho Clinical Diagnostics Inc

See all →

Moderate
Lactate slides in 18-slide cartridges recalled over calibration failures delaying results
FDA (Devices) · 2025-09-24
Moderate
Lactate test slides recalled over calibration failures delaying patient results
FDA (Devices) · 2025-09-24
Moderate
Calcium test slides recalled after calibration failures delayed patient results
FDA (Devices) · 2025-08-27
High
VITROS Performance Verifier II lots can cause quality control drift
FDA (Devices) · 2025-07-23
High
VITROS CHE slides sold in Japan can cause quality control drift
FDA (Devices) · 2025-07-23

Same hazard · performance defect