FDAJuly 29, 2025device

VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750004454353301302947353301302972353301303001353301303002353301303048353301303084353301315887353301315958353301315962353301316058

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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