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AQUIOS TETRA-2+ REAGENT KIT (2015-10-02)
- Starting date:
- October 2, 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-55704
Affected Products
AQUIOS TETRA-2+ REAGENT KIT
Reason
The 2D barcodes on the AQUIOS Tetra-1 and Tetra-2+ Reagent Vials and the AQUIOS Lysing Reagent incorrectly encoded thirty (30) days for the open container stability. The correct open vial stability claim, as stated in the instructions for use (IFU), is ninety (90) days for the AQUIOS Tetra-1 and AQUIOS Tetra-2+ Reagents, and eighty (80) days for the AQUIOS Lysing Reagent.
Affected products
AQUIOS TETRA-2+ REAGENT KIT
Lot or serial number
6090004K
Model or catalog number
B23534
Companies
- Manufacturer
-
Beckman Coulter Ireland
Lismeehan, O'Callaghan's Mills
County Clare
IRELAND