Home / Recalls / Cell Marque Corporation / Z-2038-2016

Z-2038-2016 Class II Terminated

Recalled by Cell Marque Corporation — Rocklin, CA

Recall Details

Product Type
Devices
Report Date
June 29, 2016
Initiation Date
May 10, 2016
Termination Date
September 23, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23 units

Product 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 for Recall

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.

Distribution Pattern

Distributed in the states of MA, CA, and WA and the countries of Australia, Denmark, Turkey, Germany, Russia, Slovenia, Netherlands and Zambia.

Code Information

Lot codes: 1335409A 1335409D 1335409B 1335409E 1335409C 1335409F.

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