Alinity m System Software Issue Affects Maintenance and Diagnostics Procedures
Abbott Molecular is recalling 742 Alinity m System units worldwide due to a software issue that prevents Field Service Engineers from properly completing maintenance and diagnostics procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device with a software defect affecting critical maintenance and diagnostics procedures. No reported illnesses or injuries, but this represents a risk-of-harm product where proper device servicing cannot be completed.
Plain-English summary
Abbott Molecular, Inc. is recalling 742 units of the Alinity m System, Part No. 08N53-002, distributed worldwide across the United States and 43 additional countries. The recall affects all serial numbers of this model.
The recall is due to a software issue that prevents Field Service Engineers from properly completing maintenance and diagnostics procedures on the device. This functional defect could impact the ability to service and diagnose the system.
There are no reported injuries or illnesses associated with this recall. Customers who have received affected units should contact Abbott Molecular for instructions on software remediation.
The recalled product
- Product
- Alinity m System, Part No. 08N53-002
- Manufacturer
- Abbott Molecular, Inc.
- Affected units
- 742
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 (3)
- Alinity m System
- Model 08N53-002
- all serial numbers
Distribution
Distributed nationwide across the United States.
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