This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
COLORWRIGHT PHOSPHATE BUFFER SOLUTIONS (2016-01-21)
- Starting date:
- January 21, 2016
- Posting date:
- February 8, 2016
- 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-57030
Affected Products
A. COLORWRIGHT PHOSPHATE BUFFER SOLUTION, PH 6.8 3.78L
B. COLORWRIGHT PHOSPHATE BUFFER SOLUTION, PH 7.2
Reason
The label for ColorWright Phosphate Buffer Solutions distributed in Canada lacks the manufacturer's name and address as required in Canadian Medical Devices Regulations (sor/98-282), subsection: Labelling Requirements 21 (1).
Affected products
A. COLORWRIGHT PHOSPHATE BUFFER SOLUTION, PH 6.8 3.78L
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ACC-SP5548
Companies
- Manufacturer
-
ASTRAL DIAGNOSTICS, INCORPORATED
1224 FOREST PARKWAY, SUITE 200
WEST DEPTFORD
08066
New Jersey
UNITED STATES
B. COLORWRIGHT PHOSPHATE BUFFER SOLUTION, PH 7.2
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ACC-SPP5573
Companies
- Manufacturer
-
ASTRAL DIAGNOSTICS, INCORPORATED
1224 FOREST PARKWAY, SUITE 200
WEST DEPTFORD
08066
New Jersey
UNITED STATES