Health product recall

Alinity i Processing Module (2019-04-09)

Starting date:
April 9, 2019
Posting date:
April 18, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69652

Last updated: 2019-04-18

Affected Products

Alinity i Processing Module

Reason

There is a potential for loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. A loose cable connection has the potential to heat up and cause damage to the wire and connector. If this occurs, the operator may detect a burning smell. The cable connection to the reagent cooler is located within the processing module and is not intended to be accessed by the operator. Due to the very low flammability rating of the materials used, any heat damage would be localized to the connectors. The cable connections on the reagent cooler have been redesigned to include more robust connectors.

Affected products

Alinity i Processing Module

Lot or serial number
  • AI01053
  • AI01072
  • AI01112
  • AI01133
  • AI01242
Model or catalog number

03R65-01

Companies
Manufacturer

Abbott GmbH & Co. KG

Max-Planck-Ring 2

Wiesbaden

65205

GERMANY