Health product recall

Alinity C system Optics Assembly (2020-05-20)

Starting date:
May 20, 2020
Posting date:
May 29, 2020
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-73209

Last updated: 2020-05-29

Affected Products

Alinity C system Optics Assembly

Reason

This Product Correction letter is to inform you of an issue with the Alinity c system Optics Assembly (part number C-35016278-01).  Abbott has identified the potential for a nonlinear optics response due to an issue with the Alinity c optics.  The issue is with the diffraction grating within the optics assembly and can result in a lower than expected absorbance value.

Affected products

Alinity C system Optics Assembly

Lot or serial number

All lots.

Model or catalog number

03R67-01

Companies
Manufacturer
Abbott GmbH
Max Planck Ring 2
Wiesbaden
65205
GERMANY