Ortho-Clinical recalls LAC Slides with coating 0130+ due to increased calibration failures causing delayed lab results. Affected units may impact patient care; check catalog number 8433880 and lot numbers for details.
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.
Ortho-Clinical is recalling LAC Slides used in lab testing because some batches cause calibration failures on specific machines. This delay in test results could affect patient care if not corrected.
The slides have a higher failure rate (1%) when used with coating 0130 or newer on VITROS XT 3400 and 7600 systems compared to other coatings (0.06%). This causes calibration errors that delay lab results and might affect patient management.
Lab users with the recalled LAC Slides (catalog 8433880) are most at risk. Patients receiving tests using these slides may experience delayed results.
Check for catalog number 8433880 and lot numbers starting with 3533-0130-2317 to 3533-0131-6128. The slides expire between September 2026 and January 2027.
Look for catalog number 8433880 and lot numbers listed in the recall notice to confirm if your slides are affected.
Ortho-Clinical identified a higher failure rate (1%) for coating 0130+ compared to other coatings (0.06%), causing calibration issues on VITROS XT 3400 and 7600 systems.
Check for catalog number 8433880 and lot numbers starting with 3533-0130-2317 to 3533-0131-6128. The slides expire between September 2026 and January 2027.
The recall does not require immediate action; check your slides and contact Ortho-Clinical if you need further assistance.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2559-2025 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2559-2025 from Ortho-Clinical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
