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Multigent Creatinine (Enzymatic)
- Starting date:
- June 2, 2017
- Posting date:
- July 6, 2017
- 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-63832
Reason
Manufacturer detected a performance issue with the reagent 1 component. This issue may result in quality control values shifting out of acceptable range, which is not resolved by recalibration. Only replacement of the impacted lots with a new lot resolves the issue. In addition, some customers have reported erratic patient results. Manufacturer's investigation has determined that this issue is isolated to the 3 impacted lots.
Affected products
Multigent Creatinine (Enzymatic)
Lot or serial number
60334Y600
60335Y600
60382Y600
Model or catalog number
8L24-31
8L24-41
Companies
- Manufacturer
-
Sentinel Ch Spa
Via Robert Koch, 2
Milan
20152
ITALY