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IMUBIND Adamts13 ELISA and Auto Ab ELISA (2014-06-26)
- Starting date:
- June 26, 2014
- Posting date:
- July 7, 2014
- 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-40389
Recalled Products
A) IMUBIND Adamts13 ELISA
B) IMUBIND Adamts13 Auto Ab ELISA
Reason
The recall is the result of Sekisui Diagnostics shipping two unlicensed In Vitro diagnostic devices into Canada to one customer.
Affected products
A) IMUBIND Adamts13 ELISA
Lot or serial number
Lot 130530, Exp: 11/15/2014
Lot 140117, Exp: 04/30/2015
Model or catalog number
813
Companies
- Manufacturer
-
Sekisui Diagnostics, LLC
500 West Ave.
Stamford
06902
Connecticut
UNITED STATES
B) IMUBIND Adamts13 Auto Ab ELISA
Lot or serial number
Lot 121024, Exp: 03/31/2014
Model or catalog number
814
Companies
- Manufacturer
-
Sekisui Diagnostics, LLC
500 West Ave.
Stamford
06902
Connecticut
UNITED STATES