FDA recall Z-3123-2017

Leica Biosystems Richmond Inc. · Class II · device

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 for recall

A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.

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.

Key facts

Status
Terminated
Initiation date
2017-07-14
Report date
2017-09-20
Termination date
2024-08-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3123-2017