Recall Z-3122-2017— 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, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods.. 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, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods.
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.