Ortho-Clinical recalls VITROS Anti-HBs Quantitative Reagent Packs (Catalog 6801925) due to potential calibration failures and false elevated results in lab tests. Affected lots include 8931-8990.
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
Ortho-Clinical is recalling VITROS Anti-HBs Quantitative Reagent Packs that may cause lab tests to show false high results or calibration failures. This could lead to incorrect diagnoses if used in medical testing.
The reagent packs may cause lab equipment to give inaccurate test results, potentially showing falsely elevated hepatitis B levels. This could lead to incorrect medical diagnoses if used in clinical settings.
Lab users who purchased the VITROS Anti-HBs Quantitative Reagent Packs (Catalog No. 6801925) with specific lot numbers between 8931-8990 are affected. Healthcare professionals using these reagents for blood tests are most at risk.
Check the catalog number on the reagent pack (6801925) and the lot number (8931-8990) to confirm if it's affected. These products were sold with specific lot numbers listed in the recall notice.
Look for the lot number on the product label, which should be between 8931 and 8990 for affected items.
Ortho-Clinical is recalling VITROS Anti-HBs Quantitative Reagent Packs with catalog number 6801925 and specific lot numbers 8931-8990.
The affected lots may experience increased calibration failures or produce falsely elevated results in hepatitis B blood tests.
No immediate action is required. Affected users should check the lot number and contact Ortho-Clinical if they have the specific lot numbers listed.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-0772-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-0772-2024 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.
