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.
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 recall affecting a medical device used in clinical diagnostics. The hazard—use of expired reagents without user awareness—represents a risk of harm to patient safety through potentially inaccurate laboratory results, and no illnesses or injuries are reported in the source text, making it a High (score 3) rather than Severe.
Plain-English summary
Abbott Laboratories is recalling the CELL-DYN Ruby hematology analyzer (Model 04U42-84, all software versions) because of a software defect that allows expired reagents to be used undetected.
When expired reagents are scanned or manually entered into the system, the device changes the expiration date to a current or future date without alerting the user that an expired reagent is being used. This practice violates the guidelines set forth in the device's Operator's Manual.
The recalled units were distributed worldwide, including to 31 U.S. states, Puerto Rico, and numerous countries across Africa, Asia, Europe, Latin America, the Middle East, and Oceania. A total of 45 units have been affected by this recall.
Users of the CELL-DYN Ruby should contact Abbott Laboratories for instructions on remediation or replacement of their device. Clinicians should review any patient results generated using this device to ensure the quality and reliability of reported data.
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
- failure-to-alert
Distribution
Distributed nationwide across the United States.
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