Official recall record
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-07-29
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10758750004454
- Brand on record
- Ortho-Clinical Diagnostics, Inc.
- Product category
- Medical Device
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
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