The Recall Desk

FDA (Devices) recall action 97409

Ortho-Clinical Diagnostics, Inc. recalled 2 products on 2025-09-24

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-09-24
Critical
0
Units
5,228

Why these products were recalled

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 coa…

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2025-09-24

    Lactate slides in 18-slide cartridges recalled over calibration failures delaying results

    VITROS Chemistry Products LAC Slides, catalog 8150112, from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,320 units are affected.

    Product
    VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2025-09-24

    Lactate test slides recalled over calibration failures delaying patient results

    VITROS Chemistry Products LAC Slides from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,908 units are affected.

    Product
    Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
    Category
    Distribution
    0 states