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Ammonia L3K Assay
- Starting date:
- November 29, 2016
- Posting date:
- December 13, 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-61416
Reason
Internal testing performed by Sekisui Diagnostics has determined that certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.
Affected products
Ammonia L3K Assay
Lot or serial number
- 48967
- 49330
- 49331
- 49515
Model or catalog number
- 293-10
Companies
- Manufacturer
-
Sekisui Diagnostics P.E.I. Inc.
70 Watts Avenue
Charlottetown
C1E 2B9
Prince Edward Island
CANADA