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Health product recall

4 mL K2 EDTA tube (2016-07-27)

Starting date:
July 27, 2016
Posting date:
August 19, 2016
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-59858

Affected products

  1. 4 mL K2 EDTA tube

Reason

During the process of market surveillance, we became aware that a small amount of 4 ml K2 EDTA tubes may contain a higher concentration of K2 EDTA additive. The deviation is clearly visible by tubes containing a liquid instead of sprayed dried additive.

Affected products

A. 4 mL K2 EDTA tube

Lot or serial number

B16013CW

Model or catalog number

454209CA

Companies
Manufacturer
Greiner Bio One GmbH
Bad Haller Strasse 32
kremsmeunster
4550
AUSTRIA