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

FDA Device Recall #Z-2105-2021 — Class II — May 27, 2021

Recall Summary

Recall Number Z-2105-2021
Classification Class II — Moderate risk
Date Initiated May 27, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cell Marque Corporation
Location Rocklin, CA
Product Type Devices
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

Lot / 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 from Cell Marque Corporation

Recall # Classification Product Date
Z-2311-2021 Class III Cell Marque Antibodies, PSA (ER-PR8) Mouse Mono... Jul 15, 2021
Z-2106-2021 Class II Cell Marque Antibodies, MSH6 (44), Mouse Monocl... May 27, 2021
Z-2210-2017 Class II HHV-8 (13810); 1.0 ml catalog number 265M-16; ... May 5, 2017
Z-2202-2017 Class II H. pylori (polyclonal} 1.0 mL Catalog number 2... May 5, 2017
Z-2203-2017 Class II Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog n... May 5, 2017

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.