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Use caution Medical device recall · FDA · Published August 5, 2023

Ortho-Clinical Diagnostics VITROS ALKP Slides Recall: Incorrect Liver Disease Results Risk

Ortho-Clinical Diagnostics recalls VITROS XT ALKP Slides that may give false low liver disease results. Affected units have specific product codes and expiry dates. Stop using if you have these slides to avoid missed diagnoses.

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

🇺🇸 FDA recall #Z-2624-2023Medical deviceOrtho-Clinical Diagnostics ›
Take action

Contact the company

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

Ortho-Clinical Diagnostics is recalling VITROS XT ALKP Slides that may give false low liver disease results. This could lead to missed or delayed diagnosis of liver disease if the slides are used without the system detecting a substrate depletion error. Read more at govinfonow.com/recall/57533-ortho-clinical-diagnostics-vitros-alkp-slides-recall-incorrect-liver-disease.

Source Summary by GovInfoNow · govinfonow.com/recall/57533-ortho-clinical-diagnostics-vitros-alkp-slides-recall-incorrect-liver-disease · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2624-2023

Cite this page

“Ortho-Clinical Diagnostics VITROS ALKP Slides Recall: Incorrect Liver Disease Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57533-ortho-clinical-diagnostics-vitros-alkp-slides-recall-incorrect-liver-disease. Based on FDA recall #Z-2624-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2624-2023%22&limit=1).

The FDA announced on Aug. 5, 2023, that Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry Products ALKP Slides because they may report incorrect values, potentially leading to missed or delayed diagnosis of liver disease. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: Ortho-Clinical Diagnostics
  • Product: VITROS XT Chemistry Products ALKP Slides
  • Product Code: 1053180
  • UDI: (10758750008346)
  • Lot/Gen #21; Expiry Date Range 01 Jul 2023 - 01 June 2024
  • Lot/Gen #23; Expiry Date Range 01 Oct 2023 - 01 Sep 2024
  • Lot/Gen #26; Expiry Date Range 01 Aug 2023 - 01 Dec 2024
  • Lot/Gen #28; Expiry Date Range 01 Aug 2024
  • Lot/Gen #29; Expiry Date Range 01 Sep 2024 - 01 Dec 2024
  • Lot/Gen #30; Expiry Date Range 02 Jan 2025
  • Units affected: 402,966

The hazard

Samples containing high levels of ALKP or an interfering substance could deplete the available substrate in the reagent layer of a VITROS ALKP Slide without posting the substrate depletion code. This may result in the system reporting an incorrect value lower than the actual value, which may result in missed or delayed diagnosis of liver disease.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics has issued 53 other recalls since July 10, 2017. Recent similar product recalls include the TECHNO-PATH Multichem ID-B Serum Recall (Oct. 17, 2025), the Diagnostica Stago STA Staclot Protein S Recall (July 29, 2026), and the Vivoo Protein Test Recall (Nov. 22, 2025).

How to tell if you have this one

Check for product codes: 1053180 UDI:(10758750008346) with generation numbers 21-30 and specific expiry dates listed in the recall.

  • Brand
    Ortho-Clinical Diagnostics
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide Distribution: US (nationwide) and OUS (foreign) distribution to countries of: Bermuda, Belgium, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Italy, India, Japan, Mexico, Netherlands, Norway, Singapore, Spain, Sweden, Portugal, Russia, United Kingdom
Recall numberProduct, codes & lotsQuantity
Z-2623-2023VITROS XT Chemistry Products TBIL-ALKP Slides; Product Code: 6844296 UDI: (10758750031801) GEN #16; Expiry Date Range 01 Jul 2023 - 01 Sep 2023 GEN #17; Expiry Date Range 01 Nov 2023 - 01 Feb 2024 GEN #18; Expiry Date Range 01 Apr 2024 - 01 Aug 2024 GEN #19; Expiry Date Range 01 Aug 2024 - 01 Jan 202552,456 units
Z-2624-2023VITROS XT Chemistry Products ALKP Slides; Product Code: 1053180 UDI:(10758750008346) GEN #21; Expiry Date Range 01 Jul 2023 - 01 June 2024 GEN #23; Expiry Date Range 01 Oct 2023 - 01 Sep 2024 GEN #26; Expiry Date Range 01 Aug 2023 - 01 Dec 2024 GEN #28; Expiry Date Range 01 Aug 2024 GEN #29; Expiry Date Range 01 Sep 2024 - 01 Dec 2024 GEN #30; Expiry Date Range 02 Jan 2025402,966 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the product code and generation number on the slide to confirm if it's affected.

  2. Stop Using Affected Slides

    If you have the affected product codes, stop using the slides immediately to avoid false low liver disease results.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide Distribution: US (nationwide) and OUS (foreign) distribution to countries of: Bermuda, Belgium, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Italy, India, Japan, Mexico, Netherlands, Norway,…” 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 53 days after the firm started it.

1. Firm started the recall: Aug 5, 202312. FDA classified it Class II: Sep 21, 202323. Published in FDA’s Enforcement Report: Sep 27, 202332023
  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.

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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-2624-2023 (August 5, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2624-2023 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