Health product recall

Test Thrombin Reagent (2020-04-03)

Starting date:
April 3, 2020
Posting date:
April 24, 2020
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-72861

Last updated: 2020-04-24

Affected Products

Test Thrombin Reagent

Reason

A reduced on-board stability for the test thrombin reagent on the Sysmex CA-500/CA-600 series systems may be observed.

Affected products

Test Thrombin Reagent

Lot or serial number
  • 47639
  • 47920
  • 47970
  • 48422
  • 48722
  • 49036
  • 49362
  • 49699
Model or catalog number

OWHM13

Companies
Manufacturer
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY