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Dako Beta-2-Microglobulin Kit (2015-05-06)
- Starting date:
- May 6, 2015
- Posting date:
- June 3, 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-53625
Recalled Products
A. Dako Beta-2-Microglobulin Kit
Reason
Dako has requested that Bec distribute the Dako recall notification letter, which has been issued due to the stability of the single component of the kit (Vial 1 Beta-2- microglobulin immunoparticles). According to Dako's notification, investigations have shown that a change in the Ph value in the beta-2-microglobulin immunoparticles has occurred, resulting in low or no signal for the two lowest standards in the calibration curve. In addition, the identified change in the Ph value may affect the accuracy of the beta-2-microglobulin values and results obtained, without any warnings from the instruments.
Affected products
A. Dako Beta-2-Microglobulin Kit
Lot or serial number
Not applicable
Model or catalog number
OA368
Companies
- Manufacturer
-
DAKO Denmark A/S
Produktionsvej 42
Glostrup, Copenhagen
2600
DENMARK