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PK7300 Automated Microplate System (2017-06-19)
- Starting date:
- June 19, 2017
- Posting date:
- July 7, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63864
Affected Products
A. PK7300 Automated Microplate System
B. Beckman Coulter PK7300 Automated Microplate System
Reason
Beckman Coulter has confirmed that, during sample processing under certain conditions, the PK7300 does not always generate a reagent dispensing pressure error when the reagent vial becomes empty and no reagent is dispensed.
Sample processing will continue after a vial is empty only when the reagent alarm volume, limit volume and associated mode shift alarm have not been set.
Affected products
A. PK7300 Automated Microplate System
Lot or serial number
0030221
0060227
0070235
0070236
0110255
1010262
2013030365
9010177
9110205
Model or catalog number
PK7300
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
B. Beckman Coulter PK7300 Automated Microplate System
Lot or serial number
0030221
0060227
0070235
0070236
0110255
1010262
2013030365
9010177
9110205
Model or catalog number
PK7300
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES