CELL-DYN Ruby hematology analyzer system expiration date validation
Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers (model 08H67-13) because expired reagents can be used without proper notification when their expiration dates are scanned or entered into the system.
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 of a laboratory analyzer where use of expired reagents poses a risk of incorrect patient test results. Although no illnesses or injuries are reported in the source text, the defect creates a significant harm risk by allowing unauthorized use of expired reagents without operator notification, which could affect patient care and clinical decision-making.
Plain-English summary
Abbott Laboratories is recalling the CELL-DYN Ruby hematology analyzer system (model 08H67-13, all software versions) distributed nationwide and internationally.
The system has a software defect: when expired reagents are scanned or manually entered, the system changes the expiration date to the current or future date without notifying the operator. This allows expired reagents to be used in patient testing, which violates the manufacturer's Operator's Manual guidelines.
Healthcare facilities that have received this device should contact Abbott Laboratories for instructions on correcting the software defect or obtaining a replacement system.
The recalled product
- Product
- Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
- Manufacturer
- Abbott Laboratories
- Hazard
- product-defect
- software-validation
- expired-materials
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 00380740017170 SN: 34036BG96
Distribution
Distributed nationwide across the United States.
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