CLASS III ONGOING Device recall · Reported 2 Aug 2023 · FDA Enforcement Report
Vitros Immunodiagnostic Products NT-proBNP II Range recalled
Ortho-Clinical Diagnostics is recalling Vitros Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use, distributed nationwide in the US. The recall was initiated on 18 May 2023 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2225-2023
- FDA event ID
- 92485
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 18 May 2023
- FDA classified
- 21 Jul 2023
- Reported
- 2 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 18 May 2023 | Recall initiated by company | |
| 21 Jul 2023 | Classified by FDA | +64 days |
| 2 Aug 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the state of CA.
Questions about this recall
Why was it recalled?
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Which lots are affected?
UDI-DI: 10758750033324 Lot # 0090, Expiration Date: 19-Jun-2023
Where was it sold?
US Nationwide distribution in the state of CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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