Abbott Alinity c Processing Module Recalled for Safety Interlock Defect
Abbott is recalling 559 Alinity c Processing Modules because a safety interlock may fail to deploy when a bulk solution bottle is removed.
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 medical device with a safety interlock failure that poses a risk of harm (exposure to probes), but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Abbott GmbH & Co. KG is recalling 559 units of the Alinity c Processing Module, model LN 03R67-01. The recall is due to a defect where the safety interlock covering the septum piercing probes within the bulk solution bottle holder 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 specific lot codes affected are listed in the source document.
Healthcare facilities and users should stop using the affected processing modules and contact Abbott for instructions on how to proceed with the recall.
The recalled product
- Product
- Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection…
- Manufacturer
- Abbott Gmbh & Co. KG
- Affected units
- 559
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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