Recall Z-2105-2021 ยท MVU Reagents, Specific, Analyte
Cell Marque Corporation
Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
| Date | May 27, 2021 |
| Status | Terminated |
| Reason | Product distributed for use as an In-vitro Diagnostics without FDA clearance |
| Root cause | Process control |
| Action | On May 27, 2021, Cell Marque Corporation issued a "Recall Notification" via e-mail to all affected consignee. On June 15, 2021 the firm issued a "Urgent Medical Device Recall Notification" to provide additional information. This communication was sent via e-mail. In addition to informing consignees about the recall, the firm asked customers to take the following actions: 1. Please immediately examine your inventory to determine if you have any remaining impacted product and forward a copy of this letter to the personnel in your organization that utilize this product and/or need to be made |
| Quantity | 41 kits |
| Distribution | US: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.