Health product recall

CoaguChek XS Pro and Plus, Cobas H 232 Instruments (2017-12-18)

Starting date:
December 18, 2017
Posting date:
January 29, 2018
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-65724

Affected products

  1. CoaguChek XS Plus
  2. Cobas H 232 Instruments
  3. CoaguChek XS Pro

Reason

Potential issue with imprecise touch screen response for the meters, which could lead to incorrect data entry. This issue would only occur in the manual patient ID entry screen or in the date and time entry after a meter reset. If this issue occurs, a patient ID mismatch could take place.

Affected products

A. CoaguChek XS Plus

Lot or serial number

All

Model or catalog number

4800842190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY

B. Cobas H 232 Instruments

Lot or serial number

KS02XXXXX (HBM3)

Model or catalog number

4901142190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY

C. CoaguChek XS Pro

Lot or serial number

All

Model or catalog number

5530199190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY