Ortho-Clinical VITROS NT-proBNP II Verifiers May Not Stay Stable After Expiry
Ortho-Clinical recalls VITROS NT-proBNP II Range Verifiers that may not meet stability requirements after their expiration date, risking inaccurate test results.
Lower-risk recall
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Contact the company
What happened, in plain English
Ortho-Clinical is recalling VITROS NT-proBNP II Range Verifiers that may not stay stable after their expiration date. This could lead to inaccurate test results if used beyond the expiration date. Read more at govinfonow.com/recall/58167-ortho-clinical-vitros-nt-probnp-ii-verifiers-may-not-stay.
Source Summary by GovInfoNow · govinfonow.com/recall/58167-ortho-clinical-vitros-nt-probnp-ii-verifiers-may-not-stay · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2225-2023
Cite this page
“Ortho-Clinical VITROS NT-proBNP II Verifiers May Not Stay Stable After Expiry.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58167-ortho-clinical-vitros-nt-probnp-ii-verifiers-may-not-stay. Based on FDA recall #Z-2225-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2225-2023%22&limit=1).
Why it’s dangerous
These verifiers may not meet stability specifications for shelf life as stated in the product instructions. This could cause inaccurate test results if used after the expiration date.
Who’s affected
Healthcare facilities using these verifiers for in vitro diagnostic testing are affected. Patients relying on accurate NT-proBNP tests may be at risk if the verifiers become unstable.
How to tell if you have this one
Check for catalog number 6192257 and lot number 0090. The expiration date is June 19, 2023, and the product is for in vitro diagnostic use only.
- Brand
Ortho-Clinical- Category
Medical device
What to do — step by step
Check Expiration Date
Verify the expiration date on the product label; if it's June 19, 2023 or earlier, it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2225-2023 (May 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2225-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.