Device product
SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods.
Z-2038-2016
Product summary
- Event
- Event 74179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23 units
- Official record key
device-enforcement:Z-2038-2016
Official wording
Reason: Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result.
Code information: Lot codes: 1335409A 1335409D 1335409B 1335409E 1335409C 1335409F.
Distribution pattern: Distributed in the states of MA, CA, and WA and the countries of Australia, Denmark, Turkey, Germany, Russia, Slovenia, Netherlands and Zambia.
Derived failure modes
-
Unknown
Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result.