FDA recall Z-2105-2021

Cell Marque Corporation · Class II · device

Product

Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798

Reason for recall

Product distributed for use as an In-vitro Diagnostics without FDA clearance

Distribution

US: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A

Key facts

Status
Terminated
Initiation date
2021-05-27
Report date
2021-07-28
Termination date
2024-04-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rocklin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2105-2021