Device product
CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.
Z-1000-2015
Product summary
- Event
- Event 70107
- Status
- Terminated
- Classification
- Class II
- Quantity
- 165 units
- Official record key
device-enforcement:Z-1000-2015
Official wording
Reason: One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
Code information: Lot number 4220622, Expiry 2016-04-30.
Distribution pattern: Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.
Derived failure modes
-
Unknown
One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.