VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
Enforcement
- Recall Number
- Z-2560-2025
- Event ID
- 97409
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ortho-Clinical Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 24, 2025
- Initiation Date
- July 29, 2025
- Classification Date
- September 12, 2025
- Address
- 100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States
Description
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 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.
Catalog number 8150112; UDI# 10758750004454; Coating 0130 and above, this includes Lot numbers 3533-0130-2947, 3533-0130-2972, 3533-0130-3001, 3533-0130-3002, 3533-0130-3048, 3533-0130-3084, 3533-0131-5887, 3533-0131-5958, 3533-0131-5962, 3533-0131-6058 ; Expiration date range 01-Oct-2026 to 01-Jan-2027
US Nationwide distribution.
2,320 units