VITROS XT 7600 Integrated System, Catalog No. 6844461
Class I - DangerousWhat Should You Do?
- Check if you have this product: VITROS System Software Version 3.8.1 UDI-DI 10758750031610 Serial Numbers US: J76000199 J76001383 J76000207 J76001385 J76000353 J76001392 J76000456 J76001404 J76000459 J76001406 J76000460 J76001516 J76000468 J76001518 J76000495 J76001519 J76000502 J76001520 J76000561 J76001581 J76001207 J76001583 J76001230 J76001611 J76001231 J76001620 J76001232 J76001644 J76001235 J76001647 J76001239 J76001660 J76001260 J76001668 J76001263 J76001671 J76001270 J76001674 J76001274 J76001692 J76001331 J76001700 J76001351 J76001748 OUS: J76000118 J76001070 J76000253 J76001074 J76000265 J76001095 J76000274 J76001121 J76000281 J76001130 J76000370 J76001152 J76000447 J76001174 J76000475 J76001328 J76000620 J76001377 J76000855 J76001378 J76000856 J76001396 J76000898 J76001399 J76000901 J76001407 J76000973 J76001408 J76000976 J76001484 J76001001 J76001673 J76001027 J76001761 J76001035
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ortho-Clinical Diagnostics, Inc.
- Reason for Recall:
- A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
VITROS XT 7600 Integrated System, Catalog No. 6844461
Product Codes/Lot Numbers:
VITROS System Software Version 3.8.1 UDI-DI 10758750031610 Serial Numbers US: J76000199 J76001383 J76000207 J76001385 J76000353 J76001392 J76000456 J76001404 J76000459 J76001406 J76000460 J76001516 J76000468 J76001518 J76000495 J76001519 J76000502 J76001520 J76000561 J76001581 J76001207 J76001583 J76001230 J76001611 J76001231 J76001620 J76001232 J76001644 J76001235 J76001647 J76001239 J76001660 J76001260 J76001668 J76001263 J76001671 J76001270 J76001674 J76001274 J76001692 J76001331 J76001700 J76001351 J76001748 OUS: J76000118 J76001070 J76000253 J76001074 J76000265 J76001095 J76000274 J76001121 J76000281 J76001130 J76000370 J76001152 J76000447 J76001174 J76000475 J76001328 J76000620 J76001377 J76000855 J76001378 J76000856 J76001396 J76000898 J76001399 J76000901 J76001407 J76000973 J76001408 J76000976 J76001484 J76001001 J76001673 J76001027 J76001761 J76001035
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1228-2024
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Ortho-Clinical Diagnostics
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VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Ortho-Clinical Diagnostics
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.