Rappel de produits de santé

ORTHO VISION (2019-07-16)

Starting date:
July 16, 2019
Posting date:
July 26, 2019
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-70537

Last updated: 2019-07-26

Affected Products

  1. ORTHO VISION Analyzer
  2. ORTHO VISION Max Analyzer

Reason

Due to a software anomaly on ORTHO VISION and ORTHO VISION Max Analyzers configured with software version 5.12.3 or 5.12.4, flushing of the Pipette may occur in an unexpected location after the Pipette arm (PIPA) exits IDLE mode and moves away from the Wash Station while refilling the Liquid System (LSYS) with saline.

Affected products

A. ORTHO VISION Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

6904577

Companies
Manufacturer

ORTHO-CLINICAL DIAGNOSTICS INC.

1001 US HWY 202

Raritan

08869

New Jersey

UNITED STATES

B. ORTHO VISION Max Analyzer

Lot or serial number

70002012
70002013
70002021
70002022
70002027

Model or catalog number

6904576

Companies
Manufacturer

ORTHO-CLINICAL DIAGNOSTICS INC.

1001 US HWY 202

Raritan

08869

New Jersey

UNITED STATES