Reported Aug 2, 2023 · Ongoing
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying…
Ortho-Clinical Diagnostics, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- 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 Number6192257
- Lot number0090
- Lot codes and dates
- UDI-DI10758750033324 Lot # 0090
- Expiration Date19-Jun-2023
- Amount recalled
- 2 units
Where it was sold
- Nationwide
- CA
Why it was recalled
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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