Device product
BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Z-2481-2021
Product summary
- Event
- Event 88453
- Status
- Terminated
- Classification
- Class II
- Quantity
- 237 units
- Official record key
device-enforcement:Z-2481-2021
Official wording
Reason: Product may not perform as specified in IFU.
Code information: Product Code PA0375, Lot 69909
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Product may not perform as specified in IFU.