Medical analyzer software permits expired reagent use without notification
Abbott's CELL-DYN Ruby analyzer has a software defect allowing expired reagents to be used without notification. The system incorrectly changes expiration dates to current or future dates.
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 medical device recall involving a software defect that permits use of expired reagents without proper user notification. The defect creates risk of inaccurate laboratory results in a risk-of-harm product, though no injuries have been reported.
Plain-English summary
Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers (Model 08H67-01) due to a software defect. 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, allowing expired reagents to be used in violation of the product's Operator Manual guidelines.
The use of expired reagents could affect the accuracy and reliability of laboratory test results. Expired reagents may no longer perform to their original specifications, potentially producing inaccurate results that could impact clinical decision-making. Approximately 2,947 units have been distributed worldwide. The recall affects units with UDI-DI 00380740017170 and the specific serial numbers identified by Abbott Laboratories.
The recalled product
- Product
- Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
- Manufacturer
- Abbott Laboratories
- Hazard
- expired-reagent
- software-defect
- test-inaccuracy
Distribution
Distributed nationwide across the United States.
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