Medical device software malfunction may use expired reagents
Abbott's CELL-DYN Ruby hematology analyzer contains a software flaw that masks expired reagent warnings, potentially allowing use of expired reagents in patient testing.
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 FDA Class II recall involves a software defect that creates risk of harm through potential use of expired reagents in clinical testing. No illnesses or injuries have been reported, meeting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abbott Laboratories is recalling the CELL-DYN Ruby hematology analyzer (Model 08H67-03, all software versions) affecting 146 units distributed worldwide.
The device contains a software malfunction that automatically changes the displayed expiration date of expired reagents to current or future dates without alerting the operator. This masking prevents users from recognizing that expired reagents are being used, in direct violation of the device's Operator's Manual guidelines.
The recall affects units distributed across the United States and to clinical laboratories and healthcare facilities in more than 50 countries internationally.
Affected facilities should contact Abbott Laboratories immediately. Until remediation, operators must manually verify reagent expiration dates before use and strictly follow Operator's Manual guidelines for reagent management to ensure test accuracy and patient safety.
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
- software-defect
- expired-reagent
Distribution
Distributed nationwide across the United States.
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