Lithium Assay System (2019-07-16)
- Starting date:
- July 16, 2019
- Posting date:
- July 26, 2019
- 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-70531
Last updated: 2019-07-26
Affected Products
- Lithium Assay
- Alinity c Lithium Reagent Kit
Reason
An incident occurred on architect instrument for intermittent false high Lithium results, the cause has been identified in the carryover of LDH reagent 1 which contains Lithium when the test is performed on a sub-optimal performing instrument. To prevent occurrence of such an event, and as a preventive protection of patient health, an additional smartwash step is recommended for the Lithium assay. A field action is required in order to advise end users to add this additional step.
Affected products
A. Lithium Assay
Lot or serial number
71175Y600
80201Y600
80362Y600
80424Y600
80463Y600
80533Y600
80605Y600
90208Y600
Model or catalog number
8L25-30
Companies
- Manufacturer
-
Sentinel Ch Spa
Via Robert Koch, 2
Milan
20152
ITALY
B. Alinity c Lithium Reagent Kit
Lot or serial number
80444Y600
80553Y600
80625Y600
90224Y600
Model or catalog number
08P5320
Companies
- Manufacturer
-
Sentinel Ch Spa
Via Robert Koch, 2
Milan
20152
ITALY