Stratus CS 200 Acute Care Diagnostics System (2019-03-19)

Starting date:

March 19, 2019

Posting date:

April 29, 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-69780

Last updated: 2019-04-30

• Reason
• Affected products

Affected Products

Stratus CS 200 Acute Care Diagnostics System

Reason

While using a POCT-1A communication protocol, the following error codes will not be sent from the Stratus CS 200 to the LIS.
- CH1H
- CH1L
- CH1M
- CH1N
- CH2H
- CH3H
- CS1K
- CS1V
The error messages will show on the instrument display and printout with the exception of CS1v. CS1V will only be displayed on the instrument as it indicates communication with the lis is not working. The other communication protocols are not affected by this issue.

Affected products