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Lyphochek Coagulation Control (2016-08-31)
- Starting date:
- August 31, 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-60156
Affected Products
Lyphochek Coagulation Control
Reason
The manufacturer has noticed that the Level 1 Product Lyphochek coagulation control may not meet the stability data in respect of the reconstituted vials when properly closed and stored at required temperatures, as indicated in the data sheets.
Affected products
Lyphochek Coagulation Control
Lot or serial number
- 744: 78421
- 745X: 78420
Model or catalog number
- 744
- 745X
Companies
- Manufacturer
-
Bio-Rad Laboratories
9500 Jeronimo Road
Irvine
92618
California
UNITED STATES