Abbott Alinity i Processing Module Recalled for Safety Interlock Defect
Abbott is recalling Alinity i Processing Modules because a safety interlock may fail to deploy when a bulk solution bottle is removed.
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 safety interlock failure on a medical device that could expose users to hazards, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abbott GmbH & Co. KG is recalling 1,097 units of the Alinity i Processing Module (Model LN 03R65-01). The recall is due to a defect in the safety interlock covering the septum piercing probes within the bulk solution bottle holder. This interlock may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System.
The affected units were distributed worldwide, including in the United States (AR, CA, GA, ME, MN, MO, NY, OK, SC, TN, TX, UT, and VA) and numerous international locations. The product is a fully automated immunoassay analyzer used to determine the presence of antigens, antibodies, and analytes in samples.
Healthcare facilities and users should stop using the affected processing modules and contact Abbott for instructions on how to proceed. The recall number is Z-1196-2019.
The recalled product
- Product
- Abbott Alinity i Processing Module LN 03R65-01 - 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 (C
- Manufacturer
- Abbott Gmbh & Co. KG
- Hazard
- Affected units
- 1,097
Distribution
Part of a larger recall action
This product is one of 2 recalled by Abbott Gmbh & Co. KG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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