FDA Device recall Z-3125-2017
Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use
- FDA Device
- Class II
- terminated
- Published 2017-09-20
On 2017-09-20 the FDA classified a Class II recall of Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use by Leica Biosystems Richmond, citing A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3125-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-14 |
| Published | 2017-09-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Leica Biosystems Richmond |
| Distribution | US |
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.
Identifiers
| code_info | Product Code PA0808, Lot No. 47795, Exp. Date 09/24/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3125-2017%22
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