CELL-DYN Ruby Hematology Analyzer Fails to Warn of Expired Reagents
Abbott's CELL-DYN Ruby hematology analyzers contain a software bug that automatically changes expired reagent dates without notifying users, potentially allowing use of outdated reagents.
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: FDA Class II recall involving a risk-of-harm medical device (hematology analyzer) where a software flaw could allow use of expired reagents without user notification. No illnesses or injuries have been reported, keeping the score at the maximum threshold for theoretical hazards.
Plain-English summary
Abbott Laboratories is recalling the CELL-DYN Ruby hematology analyzer (Model 08H67-10, all software versions) due to a software flaw in reagent expiration date handling. When expired reagents are scanned or manually entered into the system, the analyzer automatically changes the expiration date to a current or future date without notifying the user. This behavior violates the manufacturer's Operator's Manual guidelines.
The recalled devices have been distributed worldwide, including to all U.S. states, territories, and internationally. Nineteen units are specifically identified in this recall. Use of expired reagents could potentially affect laboratory test accuracy.
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
- Hazard
- expired-reagent
- software-error
Distribution
Distributed nationwide across the United States.
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