Health product recall

Remisol Advance (2019-09-16)

Starting date:
September 16, 2019
Posting date:
October 3, 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-71139

Last updated: 2019-10-03

Affected Products

Remisol Advance

Reason

Remisol Advance archives test results and patient information on a database, which allows the use of this data for later manual review. Beckman Coulter identified a case where in a customer's database there were duplicated archived results that did not match the patient ID due to a deadlock in the database.

Affected products

Remisol Advance

Lot or serial number

All lots.

Model or catalog number
  • VERSION 1.6
  • VERSION 1.7
  • VERSION 1.8
  • VERSION 1.9
Companies
Manufacturer
Normand - Info Sasu
7 rue Frederic Degeorge
Arras Cedex
62028
FRANCE