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U.S. Department of Health and Human Services

Class 2 Device Recall MSH6 (44 Mab) CM

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  Class 2 Device Recall MSH6 (44 Mab) CM see related information
Date Initiated by Firm July 14, 2017
Create Date September 12, 2017
Recall Status1 Open3, Classified
Recall Number Z-3123-2017
Recall Event ID 78055
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
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).
Code Information Product Code PA0804, Lot No. 45973, Exp. Date 05/21/2019
Recalling Firm/
Manufacturer		 Leica Biosystems Richmond Inc.
5205 Route 12
Richmond IL 60071
For Additional Information Contact
815-678-2000
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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