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Immunoassay Quality Control Material (2015-10-07)
- Starting date:
- October 7, 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-55852
Affected Products
- Immunoassay Quality Control Material
- Immunoassay Quality Control Material
- Immunoassay Quality Control Material
- Immunoassay Quality Control Material
- Immunoassay Quality Control Material
Reason
Parathyroid hormone (PTH) is present in the control material but no claim is now made for the expected value or stability of this analyte.
Affected products
A. Immunoassay Quality Control Material
Lot or serial number
All lots
Model or catalog number
IA3112
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM
B. Immunoassay Quality Control Material
Lot or serial number
All lots
Model or catalog number
IA3109
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM
C. Immunoassay Quality Control Material
Lot or serial number
All lots
Model or catalog number
IA2638
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM
D. Immunoassay Quality Control Material
Lot or serial number
All lots
Model or catalog number
IA2639
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM
E. Immunoassay Quality Control Material
Lot or serial number
All lots
Model or catalog number
IA2640
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM