Abbott Alinity ci-series Software Recalled for Performance Issues
Abbott is recalling Alinity ci-series software version 2.6.2 and earlier due to identified potential performance issues.
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: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. This aligns with the 'High' severity score for risk-of-harm products where specific injury reports are not detailed in the source text.
Plain-English summary
Abbott Gmbh & Co. KG is recalling the Alinity ci-series software, specifically version 2.6.2 and earlier. This software is used with the Alinity i (LN 03R65-01) and Alinity c (LN 03R67-01) processing modules.
The recall was initiated because Abbott identified potential performance issues associated with the affected software versions. The agency has classified this as a Class II recall.
The affected units were distributed worldwide, including nationwide distribution in the United States across numerous states and in many international countries. A total of 2,676 units are involved in this recall.
The recalled product
- Product
- LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.
- Manufacturer
- Abbott Gmbh & Co. KG
- Hazard
- Affected units
- 2,676
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 (2)
- LN 3R70-01
- software version 2.6.2 and earlier.
Distribution
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