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Coulter PrepPlus and PrepPlus 2 (2017-05-22)
- Starting date:
- May 22, 2017
- Posting date:
- June 13, 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-63606
Affected Products
- A. Coulter PrepPlus
- B. Coulter PrepPlus 2
Reason
When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a flow cytometer, there is imprecision in the absolute counts on only the first tube in a run when compared to the rest of the tubes in the same run. The issue may generate erroneous results for the reported parameters assayed on the sample in the first tube of the flow count worklist.
Affected products
A. Coulter PrepPlus
Lot or serial number
1.00
Model or catalog number
286600
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
B. Coulter PrepPlus 2
Lot or serial number
2.04
Model or catalog number
378600
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES