Recall Z-3123-2017 ยท NJT Immunohistochemistry Reagents And Kits
Leica Biosystems Richmond Inc.
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).
| Date | Jul 14, 2017 |
| Status | Terminated |
| Reason | A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. |
| Root cause | Storage |
| Action | Advance Cancer Diagnostics sent an Urgent Medical Device Recall letter dated July 12, 2017, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to identify any affected products, discard them, and complete and return the Medical Device Acknowledgement Form by fax to 1-847-236-3000. For questions regarding this recall call 815-678-2000. |
| Quantity | 13 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.