The Recall Desk
HighFDA (Devices)·Z-1652-2025·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall involving a medical device defect that could result in unreliable patient test results if expired reagents are unknowingly used. The hazard is significant and could affect patient care, though no injuries or illnesses are reported in the source text. Per the rubric, a Class II with risk-of-harm products where injury has not yet been reported warrants a score of 3 (High).

Plain-English summary

Abbott Laboratories is recalling the CELL-DYN Ruby hematology analyzer, Model 08H67-01, all software versions. The device has a software defect that allows expired reagents to be used in patient testing.

When expired reagents are scanned or manually entered into the system, the device will change the expiration date to a current or future date without notifying the operator that an expired reagent is being used. This behavior violates the operator's manual guidelines for proper reagent management.

Use of expired reagents may compromise the accuracy and reliability of patient test results. The recall affects devices distributed worldwide, including to customers across multiple U.S. states and numerous countries.

Operators should immediately discontinue use of this device and contact Abbott Laboratories for guidance on service or replacement. Customers should review their reagent management procedures and verify that only non-expired reagents are currently in use.

The recalled product

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
Manufacturer
Abbott Laboratories
Category
Medical Device — Hematology / Laboratory Equipment
Hazard
Affected units
2,947

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Abbott Laboratories under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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