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Vacuette 4 mL FX Sodium/Fluoride /Potassium oxal
- Starting date:
- July 27, 2016
- Posting date:
- September 23, 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-60346
Affected products
Reason
During the process of market surveillance, manufacturer 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
Vacuette 4 mL FX Sodium/Fluoride /Potassium oxal
Lot or serial number
B16013CW
B16013CW
Model or catalog number
454209CA
454209CA
Companies
- Manufacturer
-
Greiner Bio One Gmbh
Bad Haller Strasse 32
Kremsmuenster
4550
AUSTRIA