Ortho-Clinical Diagnostics, Inc. — Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 29, 2025
US Nationwide distribution.
What's affected?
- Product
- Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
- Lot code
- 3533-0130-2317
Additional details
Catalog number 8433880; UDI# 110758750004911; Coating 0130 and above, this includes Lot numbers 3533-0130-2317, 3533-0130-2717, 3533-0130-2718, 3533-0130-2719, 3533-0130-4546, 3533-0130-4605, 3533-0131-4763, 3533-0131-6114, 3533-0131-6115, 3533-0131-6116, 3533-0131-6128; Expiration date range 01-Sep-2026 to 01-Jan-2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2,908 units.
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