Ortho-Clinical recalls VITROS Anti-HBs Calibrators due to potential for positively biased results over shelf life. Affected lots manufactured between October 2023 and December 2023.
Potential for positively biased results due to signal reduction over shelf life.
Ortho-Clinical is recalling VITROS Anti-HBs Calibrators because they may give falsely high results over time. This could lead to inaccurate hepatitis B tests if used after the expiration date.
The calibrators may show falsely high results as they age, leading to inaccurate hepatitis B test outcomes. This happens due to signal reduction over the product's shelf life.
Lab technicians and healthcare facilities using these calibrators for hepatitis B testing. The risk is low as the issue only affects results over time, not immediate safety.
Check for the model number 6801926 on the calibrator pack. Products were manufactured in October or December 2023 with specific lot numbers (9010 or 9030).
Look for lot numbers 9010 (manufactured October 13, 2023) or 9030 (manufactured December 9, 2023) on the calibrator pack.
The calibrators may give falsely high results as they age, leading to inaccurate hepatitis B test outcomes.
Check the lot number on the calibrator pack. If it's 9010 or 9030, contact Ortho-Clinical for instructions.
No, this is a low-risk issue related to test accuracy, not physical safety.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2142-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2142-2024 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.
