Health product recall

ORTHO VISION ANALYZER (2020-12-22)

Starting date:
December 22, 2020
Posting date:
January 7, 2021
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-74707



Last updated:
2021-01-07

Affected Products 

A. ORTHO VISION ANALYZER

B. ORTHO VISION MAX ANALYZER

Reason

Due to a software anomaly on Ortho Vision and Ortho Vision Max Analyzers configured with software version 5.12.8 Or 5.13.0, flushing of the pipette may occur in a reagent vial after the Pipette Arm (PIPA) exits idle mode, one or more reagent/diluent vials are loaded on the system and the operator enters maintenance mode before the analyzer completes the reagents inventory.

Affected products

A. ORTHO VISION ANALYZER

Lot or serial number

Software ver 5.12.8 and 5.13.0

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

Software ver 5.12.8 and 5.13.0

Model or catalog number

6904576

Companies
Manufacturer

ORTHO-CLINICAL DIAGNOSTICS INC.

1001 US HWY 202

Raritan

08869

New Jersey

UNITED STATES