Cobas Chemistry Analyzers (2017-03-15)

Starting date:

March 15, 2017

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-63144

• Reason
• Affected products

Affected Products

A. Cobas 6000 - C501 Chemistry Analyzer
B. Cobas 4000 - Cobas C 311
C. ISE1800 Additional Module For Cobas 8000
D. 559756  Cobas 8000-C502 Chemistry Analyzer
E. Cobas 8000-C701 Chemistry Analyzer
F. Cobas 8000-C702 Chemistry Analyzer

Reason

Following a production change of connector types for the sample probe plug, it was confirmed by the manufacturer that in very rare cases, a disturbance of the sample liquid level detection (LLD) may occur. This may cause the affected sample probe to dip into the sample material deeper than intended, causing the affected sample probe to be washed inadequately and lead to a potential carryover.

Affected products