Recall Z-3123-2017— Leica Biosystems Richmond Inc.
Class II · Terminated
Class II FDA medical device recall by Leica Biosystems Richmond Inc., initiated 2017-07-14, terminated 2024-08-02. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Leica Biosystems Richmond Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-14
- Terminated
- 2024-08-02
- Firm location
- Richmond, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.