VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1) Product Code 6802413 UDI 10758750002740; Serial Numbers J56000024 J56003358 2) Product Code 6802915 (Refurbished) UDI 10758750007110 Serial Numbers: 56000427 56000750 56001012 56001535 56001152 56001641 56000327 56000585 56001437 56000786 56000255 56001235 56000792 56001062 56000308 56001184 56000315 56000458 56001570 56000825 56000661 56000261 56000559 56000818 56000747 56001139 56000317 56000513 56000755 56000883 56001334 56001445 56001141 56000756 56000824 56000718 56001021 56000339 56000741 56000727 56001131 56001558 56001530 56001089 56001264 56000646 56000655 56001027 56001128 56000796 56000890 56000928 56001359 56001851 56000533 56001111 56001689
- 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
- Reason for Recall:
- Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Product Codes/Lot Numbers:
1) Product Code 6802413 UDI 10758750002740; Serial Numbers J56000024 J56003358 2) Product Code 6802915 (Refurbished) UDI 10758750007110 Serial Numbers: 56000427 56000750 56001012 56001535 56001152 56001641 56000327 56000585 56001437 56000786 56000255 56001235 56000792 56001062 56000308 56001184 56000315 56000458 56001570 56000825 56000661 56000261 56000559 56000818 56000747 56001139 56000317 56000513 56000755 56000883 56001334 56001445 56001141 56000756 56000824 56000718 56001021 56000339 56000741 56000727 56001131 56001558 56001530 56001089 56001264 56000646 56000655 56001027 56001128 56000796 56000890 56000928 56001359 56001851 56000533 56001111 56001689
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0650-2019
Related Recalls
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
Ortho-Clinical Diagnostics
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
Ortho-Clinical Diagnostics
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
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.