Device product
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
Z-1002-2015
Product summary
- Event
- Event 70106
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-1002-2015
Official wording
Reason: Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.
Code information: Lot numbers 4155632 with expiry date of 2015-06-30. Lot 42889687 was not shipped to customers.
Distribution pattern: US Nationwide Distribution in the states of CA, NY, and MI
Derived failure modes
-
Unknown
Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.