CELL-DYN Ruby hematology analyzer expiration date software defect
Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers because a software defect allows expired reagents to be used without user notification. The system may incorrectly update expiration dates to current or future dates, contrary to the operator's manual.
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 involving a medical device with a software defect that allows use of expired reagents—a risk-of-harm scenario where the hazard (compromised test accuracy) is explicit and the potential for patient impact is significant, though no illnesses have been reported.
Plain-English summary
Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers (Model 08H67-03, all software versions) distributed worldwide. The devices have a software defect: when expired reagents are scanned or manually entered, the system changes the expiration date to a current or future date without alerting the user that an expired reagent is being used.
Use of expired reagents violates the guidelines in the Operator's Manual and could compromise test accuracy and result reliability. The recall affects 146 units with specific serial numbers distributed across the United States and internationally.
Healthcare facilities that operate affected CELL-DYN Ruby analyzers should immediately identify and remove any expired reagents from use. Users should contact Abbott Laboratories for instructions on obtaining a software fix or replacement reagents. No illnesses or adverse events related to this defect have been reported to date.
The recalled product
- Product
- Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
- Manufacturer
- Abbott Laboratories
- Hazard
- expired-reagent-use
- software-defect
- test-accuracy-compromise
Distribution
Distributed nationwide across the United States.
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