Recall Z-3125-2017— Leica Biosystems Richmond Inc.
Class II · Terminated
Class II FDA medical device recall by Leica Biosystems Richmond Inc., initiated 2017-07-14, terminated 2024-08-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing. Reason: A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements..
- Recalling firm
- Leica Biosystems Richmond Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-14
- Terminated
- 2024-08-02
- Firm location
- Richmond, IL, United States
Product description
Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing
Reason for recall
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Data sourced from openFDA. This site is unofficial and independent of the FDA.