Ortho-Clinical VITROS Anti-HBs Reagent Pack Recall: Calibration Failures Risk
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.
Lower-risk recall
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/56766-ortho-clinical-vitros-anti-hbs-reagent-pack-recall-calibration-failures.
Source Summary by GovInfoNow · govinfonow.com/recall/56766-ortho-clinical-vitros-anti-hbs-reagent-pack-recall-calibration-failures · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0772-2024
Cite this page
“Ortho-Clinical VITROS Anti-HBs Reagent Pack Recall: Calibration Failures Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/56766-ortho-clinical-vitros-anti-hbs-reagent-pack-recall-calibration-failures. Based on FDA recall #Z-0772-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0772-2024%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Ortho-Clinical- Category
Medical device
What to do — step by step
Check Reagent Lot Number
Look for the lot number on the product label, which should be between 8931 and 8990 for affected items.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Domestic distribution nationwide. OUS distribution to Bermuda, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, France,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0772-2024 (November 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0772-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.