Agency classClass IIOur severity:High FDA (Devices)·Z-1497-2019·Announced 2019-06-05

Abbott Alinity i Processing Module Recalled for Potential Burn and Shock Hazards

Abbott is recalling Alinity i Processing Modules due to potential loose cable connections that could cause reagent cooler failure, leading to burn or shock injuries.

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 risk-of-harm product (burn and shock injuries) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Abbott Gmbh & Co. KG is recalling the Alinity i Processing Module, Part Number 03R65 01, including the TED (Thermo Electric Device) Engine and specific power cables. The recall involves 373 units distributed worldwide, including nationwide distribution in the United States to Oklahoma and Texas.

The recall is issued because potential loose cable connections on the reagent cooler could result in temperature errors and eventual reagent cooler failure. This failure could cause burn and shock injuries to users and delay test results. The source notes that the device design has mitigated this risk, but the possibility remains.

Healthcare facilities and users should contact Abbott for instructions on how to address the affected components.

The recalled product

Product: Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and…
Manufacturer: Abbott Gmbh & Co. KG
Category: Medical Device — Laboratory Equipment
Hazard: burn-injury
shock-injury
Affected units: 373

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 (9)

Part Number: 03R65 01
all Serial Numbers
a. TED (Thermo Electric Device) Engine
Reagent cooler - Part Numbers A 30103732 01
A 30103732 02 with all Serial Numbers
b. CABLE
POWER OUT
TED CNTRLER - Part Numbers A 35006203 01
A 35006203 02 with all Serial Numbers

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Abbott Gmbh & Co. KG

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Same hazard · burn injury