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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.

FDA Recall Z-2038-2016 · Posted None

Recalling FirmCell Marque Corporation
Recall StatusTerminated
Product CodeNJT
Date Initiated2016-05-10
Date Terminated2016-09-23
Product Quantity23 units

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.

Firm 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.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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