The Recall Desk
Severity pendingFDA (Devices)·Z-2560-2025·Announced 2025-09-24

VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges

Pending LLM rewrite. Source: FDA_DEVICE Z-2560-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

The recalled product

Product
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
Manufacturer
Ortho-Clinical Diagnostics, Inc.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • 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

Distribution

Distributed nationwide across the United States.

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