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TEG Hemostasis System Level II Control (2015-01-26)
- Starting date:
- January 26, 2015
- Posting date:
- February 16, 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-43725
Recalled Products
A) TEG Hemostasis System Level II Control
Reason
Specific lots of level II control kits may produce results with an out-of-range high MA (maximum amplitude). The discordant high result may be elevated by 1 - 6 mm, yielding results as high as 47 mm.
Affected products
A) TEG Hemostasis System Level II Control
Lot or serial number
HM09200
HM09217
HM09226
HM09232
HM09276
HM09285
HM09292
Model or catalog number
8002
Companies
- Manufacturer
-
Haemonetics Corporation DBA
6231 West Howard Street
Niles
60714
UNITED STATES