Cell Marque Corporation: Medical Device Recall in 2021 - (Recall #: Z-2105-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 27, 2021

Date Posted: July 28, 2021

Recall Number: Z-2105-2021

Event ID: 88072

Reason for Recall:

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

Status: Terminated

Product Quantity: 41 kits

Code Information:

Lot Numbers: 0000058081/ Exp: 31 Dec 2021, 0000072580/ Exp: 30 Sep 2021, 0000090505/ Exp: 30 Sep 2022, 0000121052/ Exp: 31 May 2023

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated