Recall Z-3125-2017
Leica Biosystems Richmond Inc. · initiated July 14, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Product Code PA0808, Lot No. 47795, Exp. Date 09/24/2019
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.
FDA-determined cause: Storage
Action taken
Advance Cancer Diagnostics sent an Urgent Medical Device Recall letter dated July 12, 2017, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to identify any affected products, discard them, and complete and return the Medical Device Acknowledgement Form by fax to 1-847-236-3000. For questions regarding this recall call 815-678-2000.
Details
- Recall number
- Z-3125-2017
- Initiated
- July 14, 2017
- Terminated
- August 2, 2024
- Product code
- NJT – Immunohistochemistry Reagents And Kits
- Quantity
- 5
- Distribution
- Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
- Recalling firm
- Leica Biosystems Richmond Inc., Richmond, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3120-2017 Class II | Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for…A delay in transit may have contributed to nonconformity as the product was stored outside of defined… | 07/14/2017Terminated |
| Z-3121-2017 Class II | Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for…A delay in transit may have contributed to nonconformity as the product was stored outside of defined… | 07/14/2017Terminated |
| Z-3122-2017 Class II | Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803…A delay in transit may have contributed to nonconformity as the product was stored outside of defined… | 07/14/2017Terminated |
| Z-3123-2017 Class II | Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in…A delay in transit may have contributed to nonconformity as the product was stored outside of defined… | 07/14/2017Terminated |
| Z-3124-2017 Class II | Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for…A delay in transit may have contributed to nonconformity as the product was stored outside of defined… | 07/14/2017Terminated |
| Z-3126-2017 Class II | Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for…A delay in transit may have contributed to nonconformity as the product was stored outside of defined… | 07/14/2017Terminated |