Health product recall

Alinity C and I Processing Module (2018-02-22)

Starting date:
February 22, 2018
Posting date:
March 23, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66276

Affected products

A. ALINITY C PROCESSING MODULE
B. ALINITY I PROCESSING MODULE

Reason

During the installation of an Alinity ci-series System Control Module (SCM01163), the Field Service Engineer observed a sharp edge and burrs and scratched his hand on the sharp edge of a Processing Module Location Flag, RSM (Part # A-30105086-01). This part is contained in both Alinity i and c modules.

Affected products

A. ALINITY C PROCESSING MODULE

Lot or serial number

Ac01001 - Ac01025
Ac01027 - Ac01069
Ac01071 - Ac01100
Ac01102 - Ac01116
Ac01118 - Ac01129

Model or catalog number

03R67-01

Companies
Manufacturer
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY

B. ALINITY I PROCESSING MODULE

Lot or serial number

Ai01001 - Ai01166
Ai01168 - Ai01172
Ai01176

Model or catalog number

03R65-01

Companies
Manufacturer
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY