FDA Device recall Z-3123-2017
Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The 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, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The 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-3123-2017 |
| 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, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC).
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 PA0804, Lot No. 45973, Exp. Date 05/21/2019 |
|---|
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-3123-2017%22
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