Various Roche and cobas Devices (2016-09-29)

Starting date:

September 29, 2016

Posting date:

November 21, 2016

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-61100

• Reason
• Affected products

Affected Products

A. ROCHE HITACHI -  MODULAR PP/DP - CLASS 3
B. COBAS 6000 - E601
C. COBAS 6000 - C501 CHEMISTRY ANALYZER
D. COBAS E 411 IMMUNOASSAY ANALYZER
E. URISYS 2400 ANALYSER
F. COBAS INTEGRA SYSTEM - COBAS INTEGRA 800 ANALYZER
G. MODULAR ANALYTICS E COMBINATIONS ANALYZER (E170)
H. COBAS INTEGRA SYSTEM - COBAS INTEGRA 800 ANALYZER
I. MODULAR PRE-ANALYTICS HITACHI MPA
J. COBAS 8000 C701 STAND ALONE CONFIGURATION
K. COBAS 8000 C502 STAND ALONE CONFIGURATION
L. COBAS 8000 E602 IMMUNOASSAY ANALYZER
M. COBAS 8000 C702 STAND ALONE CONFIGURATION
N. COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZE
O. COBAS 6500 - COBAS U701 MICROSCOPY ANALYZER
P. COBAS 6800
Q. COBAS 8800
R. COBAS C 513 ANALYZER
S. COBAS P612 PRE-ANALYTICAL SYSTEM

Reason

The manufacturer has identified during internal investigation following customer injury complaints, that a new mandatory cleaning procedure for sample rack trays was required to mitigate the risk of potential user injury.

Affected products