Abbott Alinity ci-series System Control Modules Recalled for Software Defect
Abbott is recalling 943 Alinity ci-series System Control Modules because software may fail to detect issues in specific electrolyte assays.
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria for potential diagnostic errors without confirmed adverse events.
Plain-English summary
Abbott Gmbh & Co. KG is recalling 943 Alinity ci-series System Control Modules configured with Alinity c Processing Modules. The recall covers all lots (List Number 03R70-01) and includes systems distributed worldwide, including in the United States and numerous international markets.
The recall is due to a software defect where all versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays for sodium (Na+), potassium (K+), and chloride (Cl-). This defect could result in undetected problems with these specific electrolyte measurements.
Healthcare facilities and users of these systems should contact Abbott for instructions on how to address the software issue. The source text does not specify a particular action for consumers, as these are clinical laboratory devices.
The recalled product
- Product
- The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a…
- Manufacturer
- Abbott Gmbh & Co. KG
- Affected units
- 943
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)
- List Number: 03R70-01 ALL LOTS
Distribution
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