Ortho-Clinical Diagnostics, Inc. is recalling 5,228 units of VITROS Chemistry Products LAC Slides used in clinical laboratory systems. These slides, specifically those with coating 0130 and above, are experiencing an increased rate of calibration failures (error code TH4-63J). The issue was discovered after failure rates rose to 1% in 2025 lots, which is significantly higher than the typical rate of 0.03% seen in 2024. This defect causes delays in obtaining lactate (LAC) test results, which could potentially impact the management of patients in critical care settings.
Calibration failures prevent the laboratory system from providing accurate lactate test results. This delay can hinder the timely diagnosis and treatment of patients, particularly those being monitored for serious conditions like sepsis or tissue hypoxia.
Coating 0130 and above. Used on VITROS XT 3400 and VITROS XT 7600 Systems.
Coating 0130 and above. Used on VITROS XT 3400 and VITROS XT 7600 Systems.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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