Diagnostic Verification Product May Not Meet Shelf Life Stability Specifications
Ortho-Clinical Diagnostics is recalling VITROS NT-proBNP II Range Verifiers Lot 0090 because the product may not meet shelf life stability specifications. Used for diagnostic system calibration verification.
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 III recall with no reported illnesses or injuries and no reported product failures. The hazard is theoretical—the product may not meet shelf life stability specifications. Per the rubric, FDA Class III recalls are typically scored 1 or 2; since there is a functional specification concern rather than just cosmetic or documentation issues, this warrants a Moderate rating.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling Lot 0090 of VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers. These calibration verification products are used with VITROS immunodiagnostic systems to verify proper calibration when measuring N-terminal pro Brain Natriuretic Peptide (NT-proBNP).
The recalled lot may not meet the shelf life stability specifications outlined in the product's Instructions For Use. This means the product could potentially degrade before its expiration date of June 19, 2023, which could affect the accuracy of system calibration verification.
The recall affects 2 units distributed in California. The UDI-DI is 10758750033324.
The recalled product
- Product
- VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measuremen
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 2
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 (2)
- UDI-DI: 10758750033324 Lot # 0090
- Expiration Date: 19-Jun-2023
Distribution
Related recalls
Same manufacturer · Ortho-Clinical Diagnostics, Inc.
See all →- ModerateLactate slides in 18-slide cartridges recalled over calibration failures delaying results
FDA (Devices) · 2025-09-24
- ModerateLactate test slides recalled over calibration failures delaying patient 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 CHE slides sold in Japan can cause quality control drift
FDA (Devices) · 2025-07-23
Same hazard · stability failure
See all →- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateVasocaine lidocaine spray recalled because stability data does not support expiry
FDA (Drugs) · 2026-03-11
- ModerateZone 1 lidocaine cream recalled because stability data does not support expiry
FDA (Drugs) · 2026-03-11
- ModerateZone 2 lidocaine cream recalled because stability data does not support expiry
FDA (Drugs) · 2026-03-11
- ModerateCisatracurium 20 mg multiple-dose vials recalled after subpotent assay results
FDA (Drugs) · 2025-12-24