Abbott CELL-DYN Ruby Hematology Analyzer Recall for Expired Reagent Handling Defect
Abbott is recalling CELL-DYN Ruby hematology analyzers that silently accept expired reagents without user notification, potentially allowing inaccurate laboratory test results.
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 an FDA Class II device with a defect that creates a risk of harm through potential use of expired reagents, but no illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product without reported injury, resulting in a High severity classification.
Plain-English summary
Abbott Laboratories is recalling the CELL-DYN Ruby hematology analyzer (Model 04U42-84, all software versions) due to a software defect affecting 45 units.
When expired reagents are scanned or manually entered, the system changes the expiration date to the current or future date without notifying the user. This violates the Operator's Manual guidelines and could allow the use of expired reagents, potentially compromising the accuracy of test results.
The affected units have been distributed nationwide in the United States and internationally to numerous countries. Specific serial numbers are provided in the FDA recall notice (Z-1656-2025).
The recalled product
- 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
- Manufacturer
- Abbott Laboratories
- Hazard
- expired-reagent-use
- software-defect
Distribution
Distributed nationwide across the United States.
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