The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1654-2025·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 an FDA Class II recall affecting a medical device used in clinical laboratories where reagent integrity is critical to accurate patient test results. Although no illnesses or injuries are reported in the source, the defect presents a risk of harm through potential use of expired reagents, which could compromise diagnostic accuracy and patient care.

Plain-English summary

Abbott Laboratories is recalling the CELL-DYN Ruby hematology analyzer (Model 08H67-10, all software versions) worldwide due to a software defect affecting reagent expiration date handling.

When expired reagents are scanned or manually entered into the system, the CELL-DYN Ruby automatically changes the expiration date to a current or future date without notifying the user. This change occurs silently, meaning users may unknowingly use expired reagents in violation of the Operator's Manual guidelines.

Nineteen units have been distributed in the United States across multiple states and internationally to numerous countries. Users should contact Abbott to determine if their device is affected and obtain guidance on remedial steps.

Customers and healthcare facilities using the CELL-DYN Ruby should stop using the device and contact Abbott Laboratories immediately for instructions on how to address this issue.

The recalled product

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
Manufacturer
Abbott Laboratories
Category
Medical Device — Laboratory Hematology Analyzer
Hazard
Affected units
19

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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