Use caution Medical device recall · FDA · Published July 9, 2025

Ortho-Clinical VITROS Ca Slides Recall: Calibration Failures Risk Patient Delay

Ortho-Clinical recalls VITROS Ca Slides (Gen 67+) for increased calibration failures on XT 3400/7600 systems, risking delayed calcium test results and potential patient emergencies.

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

🇺🇸 FDA recall #Z-2335-2025Medical device Ortho-Clinical ›

Use caution until it’s fixed

Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.

Take action

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 Chemistry Ca Slides from Generation 67 and above due to frequent calibration failures on their test systems. This can delay calcium test results, potentially affecting urgent treatments for conditions like hypercalcemia or parathyroid disorders. Read more at govinfonow.com/recall/51829-ortho-clinical-vitros-ca-slides-recall-calibration-failures-risk-patient.

Source Summary by GovInfoNow · govinfonow.com/recall/51829-ortho-clinical-vitros-ca-slides-recall-calibration-failures-risk-patient · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2335-2025

Cite this page

“Ortho-Clinical VITROS Ca Slides Recall: Calibration Failures Risk Patient Delay.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51829-ortho-clinical-vitros-ca-slides-recall-calibration-failures-risk-patient. Based on FDA recall #Z-2335-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2335-2025%22&limit=1).

The FDA announced on July 9, 2025, that Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Ca Slides due to calibration failures. The hazard involves delayed calcium test results that may impact patient management.

How to tell if you have it

Brand: Ortho-Clinical
Product: VITROS Chemistry Products Ca Slides
Catalog Number: 145 0261
UDI-DI: 10758750009114
Affected GENs: 67 and above

The hazard

Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems. This causes calibration failures that delay calcium test results and potentially impact patient management, including delayed diagnosis of hypercalcemic crisis or parathyroid disorders.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics has 53 other recalls on record since July 10, 2017. Other recent recalls of similar products include Ortho-Clinical VITROS LAC Slides Recall (July 29, 2025), Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (June 12, 2025), and Ortho-Clinical VITROS CHE Slides Recall (June 10, 2025). Other recent recalls of similar products include Siemens Dimension Creatinine Flex Reagent Cartridge Recall (March 18, 2026), Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026), and Beckman Coulter AU5800 Chemistry Analyzer Recall (Jan. 30, 2026).

How to tell if you have this one

Check for VITROS Ca Slides with catalog number 145 0261 and generation 67 or higher. Affected units were sold with UDI-DI: 10758750009114.

Brand
Ortho-Clinical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Slide Generation
Identify if your VITROS Ca Slide is Generation 67 or higher using the catalog number 145 0261.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore,…” 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 49 days after the firm started it.

Jul 9, 2025Firm started the recall
Aug 15, 2025FDA classified it Class II
Aug 27, 2025Published in FDA’s Enforcement Report

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

Similar recalls

Latest medical device recalls

Keep exploring

More Ortho-Clinical recalls

Link to this recall

<a href="https://govinfonow.com/recall/51829-ortho-clinical-vitros-ca-slides-recall-calibration-failures-risk-patient">Ortho-Clinical VITROS Ca Slides Recall: Calibration Failures Risk Patient Delay (GovInfoNow)</a>

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-2335-2025 (July 9, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2335-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.