Abbott Alinity C Processing Module Recalled for Incorrect Patient Results
Abbott is recalling 421 Alinity C Processing Modules because they may generate incorrect results for specific chemistry assays.
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 medical device that may generate incorrect patient results, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Abbott GmbH & Co. KG is recalling 421 serial numbers of the Alinity C Processing Module, a chemistry analyzer used for in-vitro diagnostics. The recall is due to a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.
The affected devices were distributed in 25 U.S. states, Puerto Rico, and numerous countries worldwide. The agency classification for this recall is Class II. No specific dates, lot numbers, or reported injuries are provided in the source text.
Healthcare facilities and users of these devices should contact Abbott for instructions on how to proceed with the recall and replacement or repair of the affected modules.
The recalled product
- Product
- Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
- Manufacturer
- Abbott Gmbh & Co. KG
- Hazard
- Affected units
- 421
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: 03R67-01: All serial numbers
Distribution
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