Home / Recalls / Cell Marque Corporation / Z-2105-2021

Z-2105-2021 Class II Terminated

Recalled by Cell Marque Corporation — Rocklin, CA

Recall Details

Product Type
Devices
Report Date
July 28, 2021
Initiation Date
May 27, 2021
Termination Date
April 5, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
41 kits

Product Description

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 Pattern

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

Code Information

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

Other recalls by Cell Marque Corporation

  • Z-2311-2021 Class III — Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 32 (July 15, 2021)
  • Z-2106-2021 Class II — Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, (May 27, 2021)
  • Z-2199-2017 Class II — Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog numbe (May 5, 2017)
  • Z-2203-2017 Class II — Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnost (May 5, 2017)
  • Z-2208-2017 Class II — Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte (May 5, 2017)
  • Z-2201-2017 Class II — Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte (May 5, 2017)
  • Z-2205-2017 Class II — Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyt (May 5, 2017)
  • Z-2210-2017 Class II — HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; (May 5, 2017)
  • Z-2204-2017 Class II — Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; (May 5, 2017)
  • Z-2209-2017 Class II — CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 (May 5, 2017)