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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: 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…
- 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
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