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 measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090
Reported: August 2, 2023 Initiated: May 18, 2023 #Z-2225-2023
Product Description
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 measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090
Reason for Recall
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Details
- Recalling Firm
- Ortho-Clinical Diagnostics, Inc.
- Units Affected
- 2 units
- Distribution
- US Nationwide distribution in the state of CA.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
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 measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090. Recalled by Ortho-Clinical Diagnostics, Inc.. Units affected: 2 units.
Why was this product recalled? ▼
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 2, 2023. Severity: Low. Recall number: Z-2225-2023.
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