The Recall Desk

FDA (Devices) recall action 96567

Abbott Laboratories recalled 5 products on 2025-04-30

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2025-04-30
Critical
0
Units
3,158

Why these products were recalled

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

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.

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··2025-04-30

    CELL-DYN Ruby hematology analyzer expiration date software defect

    Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers because a software defect allows expired reagents to be used without user notification. The system may incorrectly update expiration dates to current or future dates, contrary to the operator's manual.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2025-04-30

    CELL-DYN Ruby hematology analyzer system expiration date validation

    Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers (model 08H67-13) because expired reagents can be used without proper notification when their expiration dates are scanned or entered into the system.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2025-04-30

    CELL-DYN Ruby hematology analyzer medical device recall

    Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers because expired reagents may be used without user notification when scanned or manually entered into the system, contrary to manufacturer guidelines.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2025-04-30

    CELL-DYN Ruby Hematology Analyzer Expiration Date Software Defect

    Abbott's CELL-DYN Ruby hematology analyzer may accept expired reagents without alerting the operator, potentially allowing use of expired materials in patient testing.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2025-04-30

    Abbott CELL-DYN Ruby hematology analyzer affected by expired reagent date masking

    Abbott is recalling the CELL-DYN Ruby hematology analyzer because expired reagents may have their expiration dates automatically changed to current or future dates without user notification, potentially leading to use of expired reagents.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Distribution
    34 states