Z-1000-2015 Class II Terminated
FDA device recall Z-1000-2015 was initiated by BD Biosciences, Systems & Reagents on December 19, 2014 and is designated Class II. Reason for recall: One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data. The recall status is terminated (terminated February 23, 2016). Affected quantity: 165 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 28, 2015
- Initiation Date
- December 19, 2014
- Termination Date
- February 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165 units
Product Description
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.
Reason for Recall
One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
Distribution Pattern
Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.
Code Information
Lot number 4220622, Expiry 2016-04-30.