Ortho-Clinical recalls VITROS NT-proBNP II Range Verifiers that may not meet stability requirements after their expiration date, risking inaccurate test results.
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
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.
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.
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.
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.
Verify the expiration date on the product label; if it's June 19, 2023 or earlier, it's affected.
The product may not meet stability specifications for shelf life as outlined in the Instructions For Use.
The expiration date is June 19, 2023.
Look for catalog number 6192257 and lot number 0090 on the product label.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2225-2023 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2225-2023 from Ortho-Clinical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
