VITROS 6192257Recalls & reported problems
Ortho Clinical Diagnostics · VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- May 18, 2023Open, Classified
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Z-2225-2023 · Root cause: Under Investigation by firm · FDA record ↗
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- ARCHITECT 7K62-25Abbott Ireland · SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)94 reports
- ARCHITECT 08K2812Abbott GmbH · Single (specified) analyte controls (assayed and unassayed)1 recall12 reports
- CONTOUR® NEXT 9697Ascensia Diabetes Care US Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)56 reports
- McKesson 5011Mckesson Medical-Surgical Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)1 recall0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.