VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Class I - DangerousWhat Should You Do?
- Check if you have this product: VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750012343 Refurbished UD-DI 10758750033201 Serial Numbers: US: J46000208 J46000209 J46000240 J46000497 J46000864 J46000865 J46000898 J46001030 J46001064 J46001125 J46001132 J46001293 J46001462 J46001703 J46001704 OUS: J46000150 J46000933 J46000162 J46001029 J46000190 J46001041 J46000247 J46001042 J46000296 J46001087 J46000393 J46001119 J46000410 J46001186 J46000478 J46001187 J46000499 J46001210 J46000531 J46001217 J46000564 J46001289 J46000617 J46001541 J46000772 J46001565 J46000788 J46001571 J46000800 J46001609 J46000801 J46001629 J46000812 J46001639 J46000821 J46001645 J46000855 J46001680 J46000859 J46000948 J46000861 J46000983 J46000910
- 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 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which 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 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Product Codes/Lot Numbers:
VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750012343 Refurbished UD-DI 10758750033201 Serial Numbers: US: J46000208 J46000209 J46000240 J46000497 J46000864 J46000865 J46000898 J46001030 J46001064 J46001125 J46001132 J46001293 J46001462 J46001703 J46001704 OUS: J46000150 J46000933 J46000162 J46001029 J46000190 J46001041 J46000247 J46001042 J46000296 J46001087 J46000393 J46001119 J46000410 J46001186 J46000478 J46001187 J46000499 J46001210 J46000531 J46001217 J46000564 J46001289 J46000617 J46001541 J46000772 J46001565 J46000788 J46001571 J46000800 J46001609 J46000801 J46001629 J46000812 J46001639 J46000821 J46001645 J46000855 J46001680 J46000859 J46000948 J46000861 J46000983 J46000910
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1230-2024
Related Recalls
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Ortho-Clinical Diagnostics
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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.