Severity
Low
LowClass IIIOngoing
FDA Devices recall · Reported August 2, 2023
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
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ortho-Clinical Diagnostics, Inc. recalled VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use… - a low-severity action.
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use… was recalled by Ortho-Clinical Diagnostics, Inc. in August 2, 2023. Reason: May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).. Check the official notice for the remedy. Verify recall #Z-2225-2023 with the FDA Devices before acting.
The recall
Ortho-Clinical Diagnostics, Inc. issued this low-severity FDA Devices recall-May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU)..
- Low
- severity level
- 2 units
- affected scope
- Class III
- classification
- August 2, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2225-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2225-2023) was formally reported on August 2, 2023, with the manufacturer initiating the action on May 18, 2023. It is classified under Low severity (Class III), with a current status of Ongoing. Ortho-Clinical Diagnostics, Inc. is listed as the recalling firm, operating out of Rochester, NY. Federal records list the affected scope as 2 units.
The documented reason for this recall is: May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2 units
Related Recalls
6
3 from same agency
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).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-2225-2023 |
| Date reported | August 2, 2023 |
| Date initiated | May 18, 2023 |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Firm location | Rochester, NY |
| Affected scope | 2 units |
| Distribution | US Nationwide distribution in the state of CA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2225-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the state of CA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2225-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 2, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.