Abbott Recalls Alinity ci Series System Control Modules Due to Software Error
Abbott is recalling Alinity ci series System Control Modules because a software issue may cause incorrect test results after a system stop.
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 involves a risk-of-harm product (medical device) where incorrect results could impact patient care, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Abbott GmbH & Co. KG is recalling 1,763 units of the Alinity ci series System Control Module, Part Number 03R70 01. The recall covers all serial numbers and includes all on-market software versions v2.6.0 and v2.6.1. These modules are used in clinical chemistry and immunoassay analysis systems.
The recall was initiated because a software issue may cause incorrect results to occur after a system Stop. This specific issue only happens if the system is transitioned from Processing to Stopped to Idle, which leads to the Alinity i reusing reaction vessels. The product was distributed worldwide and nationwide in the US.
Healthcare facilities and users of the Alinity ci series should contact Abbott for instructions on how to address the software issue. No specific consumer action is required for the general public, as this is a medical device used in professional settings.
The recalled product
- Product
- Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a c
- Manufacturer
- Abbott Gmbh & Co. KG
- Affected units
- 1,763
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)
- All serial numbers
Distribution
Distributed nationwide across the United States.
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