Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Alinity i Processing Module Recalled by Abbott Gmbh & Co. KG Due to Abbott has identified an issue with the Alinity...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Gmbh & Co. KG directly.
Affected Products
Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
Quantity: 434 units
Why Was This Recalled?
Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) resulting in foaming/bubbling out of the bottle reservoir for Concentrated Wash Buffer and an unexpected amount of dried residue of buffer. The foaming/bubbling is a result of an improper calibration of the pump s operating speed.
Where Was This Sold?
Worldwide Distribution
About Abbott Gmbh & Co. KG
Abbott Gmbh & Co. KG has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report