VITROS Chemistry Products LAC Slides recalled after calibration failures on VITROS XT 3400 and VITROS XT 7600 systems. The recall covers catalog 8433880 with 2,908 units distributed nationwide in the US. Manufacturers warn that coating 0130 and above with Condition Code TH4-63J elevates calibration failures, delaying lac test results and potentially impacting patient management. Health providers,病
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Ortho-Clinical Diagnostics, Inc. or your healthcare provider for instructions. Notification method: Letter
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LAC Slides are used in chemistry testing on VITROS analyzers to perform lactate dehydrogenase tests; this recall concerns calibration reliability rather than direct product failure causing patient harm.
Calibration failures can delay results, potentially affecting clinical decisions and patient management.
This recall is not described as part of a broader pattern.
Delays in lab results may affect treatment timelines and patient management; facilities should verify stock and contact the manufacturer for guidance.
FDA recall page and Ortho-Clinical Diagnostics communications
Refunds/replacements timelines vary; follow manufacturer guidance
Keep recall notice, lot lists, and correspondence; document affected stock with location and quantity
Catalog number 8433880. 1 Sales Unit = 5 cartridges of 60 slides, total 300 tests. Quantity recalled: 2,908 units. UDI: 110758750004911. Coating 0130 and above. Lot numbers 3533-0130-2317 through 3533-0131-6128. Sold/distributed nationwide in the US.
No specific injury or patient harm counts are provided in the summary. The hazard is described as calibration failure and potential impact on patient management.
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