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Lifecodes PF4 IgG and Lifecodes PF4 IgG Enhanced (2014-12-10)
- Starting date:
- December 10, 2014
- Posting date:
- January 9, 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-43177
Recalled Products
A) Lifecodes PF4 IgG
B) LIfecodes PF4 Enhanced
Reason
An error was noted in the manufacture of the PF4 concentrated wash (10X) which is contained in the Lifecodes PF4 Enhanced and Lifecodes PF4 IgG kits manufactured by lmmucor GTI Diagnostics.
Affected products
A) Lifecodes PF4 IgG
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
HAT13G
HAT45G
Companies
- Manufacturer
-
Immucor GTI Diagnostics, Inc.,
20925 Crossroads Circle,
Waukesha
53186
Wisconsin
UNITED STATES
B) LIfecodes PF4 Enhanced
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
403624
Companies
- Manufacturer
-
Immucor GTI Diagnostics, Inc.,
20925 Crossroads Circle,
Waukesha
53186
Wisconsin
UNITED STATES