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.
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.
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.
The slides cause calibration failures when they generate excessive "spikes" in images, triggering a condition code that delays calcium test results. This can lead to missed urgent treatments for hypercalcemic crises or parathyroid disorders if not corrected.
Laboratory users with VITROS XT 3400 or XT 7600 systems who have Generation 67+ Ca Slides are most at risk. Patients relying on timely calcium testing could experience delayed diagnosis of critical conditions.
Check for VITROS Ca Slides with catalog number 145 0261 and generation 67 or higher. Affected units were sold with UDI-DI: 10758750009114.
Identify if your VITROS Ca Slide is Generation 67 or higher using the catalog number 145 0261.
The slides cause increased calibration failures on VITROS XT 3400 and XT 7600 systems, leading to delayed calcium test results and potential patient emergencies.
Delayed calcium test results could impact urgent treatments for conditions like hypercalcemic crisis or parathyroid disorders, requiring immediate medical attention.
Check if your slides are Generation 67 or higher with catalog number 145 0261. Contact Ortho-Clinical for guidance on next steps.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2335-2025 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2335-2025 from Ortho-Clinical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
