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Lower risk Medical device recall · FDA · Published March 1, 2024

Ortho-Clinical VITROS Anti-HBs Calibrators: Potential for biased test results

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2142-2024Medical deviceOrtho-Clinical ›
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Contact the company

Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/56026-ortho-clinical-vitros-anti-hbs-calibrators-potential-for-biased-test.

Source Summary by GovInfoNow · govinfonow.com/recall/56026-ortho-clinical-vitros-anti-hbs-calibrators-potential-for-biased-test · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2142-2024

Cite this page

“Ortho-Clinical VITROS Anti-HBs Calibrators: Potential for biased test results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56026-ortho-clinical-vitros-anti-hbs-calibrators-potential-for-biased-test. Based on FDA recall #Z-2142-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2142-2024%22&limit=1).

The FDA announced on March 1, 2024, that Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products Anti HBs Calibrators due to a potential for positively biased results. The agency issued the recall notice Z-2142-2024 for the Class II device.

How to tell if you have it

  • Brand: Ortho-Clinical
  • Product: VITROS Immunodiagnostic Products Anti HBs Calibrators
  • Model No.: 6801926
  • GTIN#: 10758750001699
  • Lot codes: 9010 (Manufactured 13-Oct-2023; Expiry 15-Jul-2024) and 9030 (Manufactured 09-Dec-2023; Expiry 26-Aug-2024)
  • Quantity: 481 units
  • Distribution: Worldwide, including US states AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WI, WV and countries Bermuda, Colombia, Singapore

The hazard

The recall addresses the potential for positively biased results due to signal reduction over shelf life. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since 2017-07-10. Recent brand recalls include the 2025-07-29 VITROS LAC Slides Recall for calibration failures and the 2025-07-09 VITROS Ca Slides Recall for similar calibration issues. Other recent recalls of similar products include Healthmark ProChek-II (2026-07-29), Beckman Coulter Access Total T4 Calibrator (2026-03-16), and Fujirebio Lumipulse G Amyloid 1-42 Plasma Calibrators (2025-12-11).

How to tell if you have this one

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).

  • Brand
    Ortho-Clinical
  • Product
    VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot

    Look for lot numbers 9010 (manufactured October 13, 2023) or 9030 (manufactured December 9, 2023) on the calibrator pack.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 31 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WI, WV and the countries of Bermuda, Colombia, Singapore.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Montana, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 4 months after the firm started it.

1. Firm started the recall: Mar 1, 202412. FDA classified it Class II: Jun 13, 202423. Published in FDA’s Enforcement Report: Jun 19, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of injury?

No, this is a low-risk issue related to test accuracy, not physical safety.

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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-2142-2024 (March 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2142-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA