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CD8 PE (Leu 2a) Reagent (2014-12-22)
- Starting date:
- December 22, 2014
- Posting date:
- January 14, 2015
- 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-43229
Recalled Products
CD8 PE (Leu 2a) Reagent
Reason
May be hazardous to health: The CD8 PE reagent is contaminated with CD4 FITC. CD4 cells will be expressed along the FITC axis. Any marker that is stained for on the FITC axis will contain this incorrectly stained CD4 population. With subsequent down gating, the results will appear as if the CD4 population is not present. This could result in the unnecessary intensification of therapy for patients already known to have reductions in their CD4 levels.
Affected products
CD8 PE (Leu 2a) Reagent
Lot or serial number
4220622
Model or catalog number
340046
Companies
- Manufacturer
-
Becton, Dickinson and Company
BD Biosciences
2350 Qume Drive
San Jose
95131
California
UNITED STATES