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).
Z-3123-2017
Product summary
- Event
- Event 78055
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13
- Official record key
device-enforcement:Z-3123-2017
Official wording
Reason: A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Code information: Product Code PA0804, Lot No. 45973, Exp. Date 05/21/2019
Distribution pattern: 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.
Derived failure modes
-
Unknown
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.