Recall Z-2105-2021— Cell Marque Corporation
Class II · Terminated
Class II FDA medical device recall by Cell Marque Corporation, initiated 2021-05-27, terminated 2024-04-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798. Reason: Product distributed for use as an In-vitro Diagnostics without FDA clearance.
- Recalling firm
- Cell Marque Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-27
- Terminated
- 2024-04-05
- Firm location
- Rocklin, CA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.