Ortho VITROS CoV2 Ag Calibrator Recalled for Calibration Failures
Ortho-Clinical Diagnostics is recalling 74 units of VITROS CoV2 Ag calibrator (Lot 0020) due to potential unexpected calibration failures.
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, and the source text describes a potential for calibration failure without reporting specific patient injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling 74 units of the VITROS CoV2 Ag calibrator (Product Code 6199950, Lot 0020). The product is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal and anterior nasal swab specimens.
The recall was initiated after Ortho investigated and confirmed the potential for unexpected failed calibration and associated condition codes when using the VITROS SARS-CoV-2 Ag Reagent Pack along with the affected calibrator lot. The affected units were distributed worldwide, including in the United States (AR, CA, IA, IL, LA, MO, MS, TX, WI) and in Colombia, India, Japan, Italy, Spain, Portugal, and France.
Healthcare facilities and laboratories should stop using the affected calibrator lot and contact Ortho-Clinical Diagnostics for further instructions or replacement.
The recalled product
- Product
- VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.
- Manufacturer
- Ortho-Clinical Diagnostics, INc.
- Hazard
- Affected units
- 74
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 (1)
- Unique Identifier: 10758750033591 Lot: 0020
Distribution
Related recalls
Same manufacturer · Ortho-Clinical Diagnostics, INc.
See all →- ModerateLactate test slides recalled over calibration failures delaying patient results
FDA (Devices) · 2025-09-24
- ModerateLactate slides in 18-slide cartridges recalled over calibration failures delaying results
FDA (Devices) · 2025-09-24
- ModerateCalcium test slides recalled after calibration failures delayed patient results
FDA (Devices) · 2025-08-27
- HighVITROS CHE slides can cause quality control drift with performance verifiers
FDA (Devices) · 2025-07-23
- HighVITROS Performance Verifier II lots can cause quality control drift
FDA (Devices) · 2025-07-23
Same hazard · calibration failure
See all →- ModeratePhosphorus reagent lots recalled because calibration may fail before expiration date
FDA (Devices) · 2025-10-15
- ModerateBeckman Coulter DxC 500 AU Chemistry Analyzer Software Calibration Error
FDA (Devices) · 2025-05-21
- ModerateBeckman Coulter Access PCT Reagent Pack Recalled for Calibration Failures
FDA (Devices) · 2025-02-12
- ModerateDRG:HYBRiD-XL Insulin Device Recalled for Calibration Failures
FDA (Devices) · 2025-01-22
Similar recalls
- ModerateOrtho Recalls VITROS SARS-CoV-2 IgG Calibrators Due to Elevated Signal Values
FDA (Devices) · 2020-11-25
- ModerateOrtho Recalls VITROS Anti-SARS-CoV-2 IgG Control Due to Signal Issues
FDA (Devices) · 2020-11-25
- ModerateVITROS COVID-19 Antibody Test Calibrators Recalled for Incorrect Calibrator Levels
FDA (Devices) · 2023-04-26
- HighOrtho-Clinical VITROS SARS-CoV-2 Antigen Reagent Pack Recall for False Results
FDA (Devices) · 2021-03-24
- HighOrtho VITROS Chemistry Calibrator Kit 2 Recalled for Potential Sodium Bias
FDA (Devices) · 2020-02-19
- HighOrtho-Clinical VITROS SARS-CoV-2 Antigen Reagent Recalled for False Results
FDA (Devices) · 2021-03-24