FDA recall Z-2481-2021

Leica Microsystems, Inc. · Class II · device

Product

BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375

Reason for recall

Product may not perform as specified in IFU.

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2021-07-30
Report date
2021-09-22
Termination date
2023-06-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Buffalo Grove, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2481-2021