Abbott Laboratories is recalling the CELL-DYN Ruby Hematology System due to a reagent software error that affects all software versions. The system may incorrectly change the expiration date of expired reagents to a current or future date without notifying the operator, allowing for the use of expired materials. This recall affects approximately 3,158 units distributed worldwide across five specific model numbers. No incidents or injuries have been reported in connection with this issue, but the manufacturer has initiated a voluntary correction to address the software behavior.
Using expired reagents can lead to inaccurate test results, which may result in incorrect patient diagnosis or improper treatment decisions. The software error masks the fact that reagents have expired by failing to provide an alert and incorrectly updating the system's internal expiration records.
Recall #: Z-1652-2025; Quantity: 2947
Recall #: Z-1653-2025; Quantity: 146
Recall #: Z-1654-2025; Quantity: 19
Recall #: Z-1655-2025; Quantity: 1
Recall #: Z-1656-2025; Quantity: 45
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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