Z-3123-2017 Class II Terminated
FDA device recall Z-3123-2017 was initiated by Leica Biosystems Richmond Inc. on July 14, 2017 and is designated Class II. 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. The recall status is terminated (terminated August 2, 2024). Affected quantity: 13.
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2017
- Initiation Date
- July 14, 2017
- Termination Date
- August 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13
Product Description
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 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.
Code Information
Product Code PA0804, Lot No. 45973, Exp. Date 05/21/2019