FDA Recall 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 · Initiated May 10, 2016

Recall

Recall Number
Z-2038-2016
Event Number
74179
Firm
Cell Marque Corporation
FEI Number
3000718726
Product Code
NJT
Status
Terminated
Root Cause
Unknown/Undetermined by firm
Initiated
May 10, 2016
Terminated
September 23, 2016
Address
6600 Sierra College Blvd, Rocklin, CA, 95677-4306

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.

Action

Product recall notifications were sent to customers on May 12, 2016. Letters advised that all unused or partially-used vials be destroyed. Customers should contact customer service for replacement and credit.

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