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Lower risk Medical device recall · FDA · Published March 26, 2021

Ortho-Clinical VITROS Black Reference Slides: Incorrect Labeling Causes Delayed Test

Ortho-Clinical recalls VITROS Black Reference Slides (catalog J0231: 9252-0058-3361, 9252-0058-3362) due to incorrect labeling as White Reference Slides. Using these may cause delayed results for most tests.

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

🇺🇸 FDA recall #Z-1489-2021Medical deviceOrtho-Clinical ›
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Contact the company

Recalling firmOrtho-Clinical Diagnostics, INc.513 Technology Blvd · Rochester, NY 14626-3601
✎ GovInfoNow plain-language explainer

Ortho-Clinical is recalling two specific lots of VITROS Black Reference Slides because they are incorrectly labeled as White Reference Slides. If used as White slides, the analyzer won't produce results for most tests, causing delays until replacement slides are delivered. Read more at govinfonow.com/recall/62900-ortho-clinical-vitros-black-reference-slides-incorrect-labeling-causes-delayed.

Source Summary by GovInfoNow · govinfonow.com/recall/62900-ortho-clinical-vitros-black-reference-slides-incorrect-labeling-causes-delayed · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1489-2021

Cite this page

“Ortho-Clinical VITROS Black Reference Slides: Incorrect Labeling Causes Delayed Test.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62900-ortho-clinical-vitros-black-reference-slides-incorrect-labeling-causes-delayed. Based on FDA recall #Z-1489-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1489-2021%22&limit=1).

The FDA announced on March 26, 2021, that Ortho-Clinical Diagnostics, Inc. recalled VITROS Black Reference Slides due to mislabeling hazards. The firm initiated this voluntary Class II recall after discovering two lots were incorrectly labeled as White Reference Slides.

How to tell if you have it

  • Brand: Ortho-Clinical
  • Product: VITROS Black Reference Slides
  • Catalog #: J02316
  • Lots: 9252-0058-3361, 9252-0058-3362

The hazard

According to the FDA, the mislabeled slides may cause the Correction Factor test to fail if used incorrectly. This failure prevents the analyzer from producing results for assays other than sodium, potassium, and chloride. The record notes this could lead to a delay in results until White Reference Slides are obtained.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since July 10, 2017. Other recent recalls of similar products include Ortho-Clinical LAC Slides Recall (July 29, 2025), Ortho-Clinical VITROS Ca Slides Recall (July 9, 2025), and Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (June 12, 2025). Other recent recalls of similar products include Orthof: Minirail Fixator M122 Labeled Incorrectly - Recall (June 10, 2026).

How to tell if you have this one

Check for the catalog number J02316 on the slides. The affected lots are 9252-0058-3361 and 9252-0058-3362. These slides are used in the VITROS analyzer for correction factor adjustments.

  • Brand
    Ortho-Clinical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Slide Labeling

    Verify if the slides are labeled as Black or White. If labeled Black but used as White, they are affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 39 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV, WY and the…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Mar 26, 202112. FDA classified it Class II: Apr 23, 202123. Published in FDA’s Enforcement Report: May 5, 202134. FDA terminated the recall: May 24, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-1489-2021 (March 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1489-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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