FDA Enforcement
Class II
Terminated
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.
Recall: Z-2038-2016
·
Reported June 29, 2016
Enforcement
- Recall Number
- Z-2038-2016
- Event ID
- 74179
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cell Marque Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 29, 2016
- Initiation Date
- May 10, 2016
- Classification Date
- June 17, 2016
- Termination Date
- September 23, 2016
- Address
- 6600 Sierra College Blvd, N/A, Rocklin, CA, 95677-4306, United States
Description
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.
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 Info
Lot codes: 1335409A 1335409D 1335409B 1335409E 1335409C 1335409F.
Distribution
Distributed in the states of MA, CA, and WA and the countries of Australia, Denmark, Turkey, Germany, Russia, Slovenia, Netherlands and Zambia.
Quantity
23 units