HemosIL Factor XII Deficient Plasma (2017-07-17)
- Starting date:
- July 17, 2017
- Posting date:
- March 13, 2018
- 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-66136
Affected products
HEMOSIL FACTOR XII DEFICIENT PLASMA
Reason
HemosIL Factor XII Deficient Plasma are not meeting their labeled on-board instrument stability claim for the ACL Top Family and ACL Top Family 50 Series of 24 hours at 15 C, the affected lots numbers are only stable for 2 hours on-board the instrument. Consequently, there is a potential risk of falsely lowered patient results if this reagent is maintain greater than 2 hours on-board the instrument.
Affected products
HEMOSIL FACTOR XII DEFICIENT PLASMA
Lot or serial number
- N0261273
- N0556645
- N0764104
- N0958653
- N1065905
Model or catalog number
20011200
Companies
- Manufacturer
-
Instrumentation Laboratory Co.
180 Hartwell Road
Bedford
01730-2443
UNITED STATES