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Synchron Systems Microalbumin Reagent
- Starting date:
- April 24, 2017
- Posting date:
- May 16, 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-63314
Reason
Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.
Internal testing has confirmed that ma is recovering within the published insert range for Beckman Coulter Urine Protein Control Level 2.
Affected products
Synchron Systems Microalbumin Reagent
Lot or serial number
M609458
Model or catalog number
475100
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES