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BD Vacutainer CPT Mononuclear Cell Preparation Tube (2014-06-27)
- Starting date:
- June 27, 2014
- Posting date:
- July 15, 2014
- 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-40551
Recalled Products
- BD Vacutainer CPT Mononuclear Cell Preparation Tube
Reason
Failure to conform to claim. Clinical performance does not meet the supporting clinical study data for percentage recovery. Poor separation, resulting in a reduced number of recovered mononuclear cells. Having an insufficient number of isolated mononuclear cells may lead to possible specimen recollection, potential delay in treatment, and in remote cases, it could lead to erroneous results. No adverse events have been reported for this issue.
Affected products
A. BD Vacutainer CPT Mononuclear Cell Preparation Tube
Lot or serial number
- 4063409
- 4090230
- 4090237
Model or catalog number
- 362753
- 362761
Companies
- Manufacturer
-
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes
07417
New Jersey
UNITED STATES