Cell Marque — Class II medical device recall Z-3122-2017
Terminated recall by Leica Biosystems Richmond Inc., reported 2017-09-20, distributed nationwide. A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping
| Recall number | Z-3122-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Biosystems Richmond Inc., Richmond, IL, United States |
| Recall initiated | 2017-07-14 |
| Classified | 2017-09-12 |
| Reported by FDA | 2017-09-20 |
| Terminated | 2024-08-02 |
| Distributed | Nationwide (US) |
| Quantity | 10 |
| Lot numbers | 46524 |
| Model numbers | PA0803 |
| Expiration dates | 2019-06-25 |
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 for recall
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3122-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.