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Acetaminophen L3K (2016-01-25)
- Starting date:
- January 25, 2016
- Posting date:
- February 8, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57012
Affected Products
A. Acetaminophen L3K
Reason
In Sept 2015, Sekisui began receiving complaints of crystal formation on R2 when left on-board an automated analyzer for an extended period. Sekisui has confirmed through testing that the chromophore used in the R2 will come out of solution and form a crystal when left on-board and exposed to air.
Affected products
A. Acetaminophen L3K
Lot or serial number
- 47649
- 47650
- 47662
- 47663
- 47694
- 47695
- 48253
- 48294
- 48385
- 48386
Model or catalog number
- 506-10
- 506-30
Companies
- Manufacturer
-
Sekisui Diagnostics P.E.I. Inc.
70 Watts Avenue
Charlottetown
C1E 2B9
Prince Edward Island
CANADA