Ortho-Clinical recalls VITROS LAC Slides with coating 0130+ due to increased calibration failures causing delayed lab results and potential patient management impacts. Affected units include specific lot numbers and expiration dates.
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 VITROS Chemistry Products LAC Slides that may cause calibration failures on certain lab systems, delaying lab results and potentially affecting patient care. This issue affects specific coating lots and expiration dates.
The LAC Slides have a higher failure rate (1%) for coating 0130+ compared to other coatings (0.06% average) and all coatings (0.03% average). This causes calibration errors on VITROS lab systems, delaying lab results and potentially impacting patient care decisions.
Lab users with VITROS XT 3400 or 7600 systems who purchased the recalled LAC Slides (catalog 8150112) between October 2026 and January 2027 are most at risk. The recall targets specific coating lots with higher failure rates.
Check for catalog number 8150112 on the slides. Affected units include coating 0130 and above with specific lot numbers listed in the recall (e.g., 3533-0130-2947) and expiration dates from October 2026 to January 2027.
Look for catalog number 8150112 and coating lots 0130+ on the slides.
The recall is due to increased calibration failures in specific coating lots (0130+) causing delayed lab results and potential patient management impacts.
Coating 0130 and above, including specific lot numbers like 3533-0130-2947 and 3533-0131-5887.
Check for catalog number 8150112 and expiration dates from October 2026 to January 2027 on the slides.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2560-2025 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2560-2025 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.
