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Health product recall

COAGUCHEK XS PLUS MONITORS ( 2015-07-23)

Starting date:
July 23, 2015
Posting date:
August 18, 2015
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-54684

Affected Products

  1. COAGUCHEK XS PLUS MONITOR
  2. COAGUCHEK XS PLUS MONITOR

Reason

The manufacturer has found a potential situation concerning the CoaguChek XS Plus Meters and the CoaguChek XS Pro Meters where a potential deficiency in providing the approved version of the operator manual when distributed to users.

Affected products

A. COAGUCHEK XS PLUS MONITOR

Lot or serial number

>10. Contact MFR.

Model or catalog number

04800842190

Companies
Manufacturer
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY

B. COAGUCHEK XS PLUS MONITOR
 

Lot or serial number

>10. Contact MFR.

Model or catalog number

05448964001

Companies
Manufacturer
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY