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MACH 4 UNIVERSAL HRP POLYMER KIT (2016-04-11)
- Starting date:
- April 11, 2016
- Posting date:
- April 29, 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-58164
Affected Products
MACH 4 UNIVERSAL HRP POLYMER KIT
Reason
A complaint investigation has identified instances of labelling errors for a specific component in the MACH 4 Universal HRP-Polymer Kit. A recall is being initiated to facilitate a field correction that could be necessary for the MACH 4 Mouse Probe vial within the MACH 4 Universal HRP-Polymer kit. It may be incorrectly labelled as MACH 4 HRP-Polymer.
Affected products
MACH 4 UNIVERSAL HRP POLYMER KIT
Lot or serial number
82715
Model or catalog number
M4U534L 100ML
Companies
- Manufacturer
-
Biocare Medical
4040 Pike Lane
Concord
94520
California
UNITED STATES