Abbott recalls Alinity i Processing Module 03R65 01 with potential loose cable connections causing temperature errors and reagent cooler failure, risking burns and shocks.
Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. Could cause burn and shock injuries to users and a delay in test results. Device design has mitigated this risk, but it is a possibility.
Abbott is recalling Alinity i Processing Module models 03R65 01 that have a potential loose cable connection in the reagent cooler. This could cause temperature errors, reagent cooler failure, and lead to burns or shocks for users. The recall is for devices that may not function properly and could pose a safety risk.
The reagent cooler in the device may have loose cable connections that cause temperature errors. This could lead to the reagent cooler failing, potentially causing burns or shocks to users and delaying test results.
Users of the Alinity i Processing Module 03R65 01 model are affected. Laboratory technicians and healthcare professionals who use this device for medical testing are most at risk due to potential safety hazards.
Check for the model number 03R65 01 on the Alinity i Processing Module. The affected units include specific part numbers for the TED Engine and power cable.
Look for the model number 03R65 01 on the Alinity i Processing Module.
Reach out to Abbott for further instructions on the recall process.
The recalled model is Alinity i Processing Module 03R65 01.
Loose cable connections could cause temperature errors, reagent cooler failure, and potentially burns or shocks to users.
Check for the model number 03R65 01 and specific part numbers for the TED Engine and power cable.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1497-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1497-2019 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
