Ortho-Clinical Diagnostics recalled 2,908 units of VITROS Chemistry Products LAC Slides on July 29, 2025. The recall affects lots from coating 0130 and above due to increased calibration failures that delay test results. The issue may impact patient management and was identified through an uptick in customer complaints.
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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The recall involves VITROS Chemistry Products LAC Slides, Catalog Number 8433880. Each sales unit contains five cartridges with 60 slides each, totaling 300 tests. The affected lots include coating 0130 and above, with specific lot numbers ranging from 3533-0130-2317 to 3533-0131-6128.
Calibration failures in the recalled slides can delay lac test results. For coating 0130, the average failure rate rose to 1% in 2025, compared to 0.06% for other coatings in the same year.
The recall follows an increase in customer complaints, indicating a significant risk in patient management. No specific injury numbers were reported.
Stop using the recalled slides immediately. Follow the recall instructions provided in the notification letter. Contact Ortho-Clinical Diagnostics or your healthcare provider for further guidance.
For assistance, contact Ortho-Clinical Diagnostics at their customer service line or visit their website. Additional information is available through the FDA recall notice.
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