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U.S. Department of Health and Human Services

Class 3 Device Recall cobas Liat Influenza A/B Quality Control Kit

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  Class 3 Device Recall cobas Liat Influenza A/B Quality Control Kit see related information
Date Initiated by Firm May 17, 2016
Date Posted July 13, 2016
Recall Status1 Terminated 3 on February 01, 2017
Recall Number Z-2203-2016
Recall Event ID 74154
510(K)Number K111387  
Product Classification Respiratory virus panel nucleic acid assay system - Product Code OCC
Product cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
Code Information Lot Numbers: 51222E, 60121H, 60201D, and 60229F
Recalling Firm/
Manufacturer		 Roche Molecular Systems, Inc.
1080 US Highway 202 S
Branchburg NJ 08876-3733
For Additional Information Contact
800-449-8506
Manufacturer Reason
for Recall		 Kit labeled with the incorrect expiration date.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action An Urgent Medical Device Recall (UMDR) notice (Customer Letter) was sent to the 35 individual affected customer sites by UPS on May 17 2016. Customers were asked to take the following actions: " Discontinue use of cobas¿ Liat Influenza A/B Quality Control kit lot numbers 51222E, 60121H, 60201D, and 60229F, and discard them per your local regulations. " Complete the enclosed UMDC faxback form (6941-00-0516) and fax it to 1-844-449-8506. " File this UMDC for future reference.
Quantity in Commerce 194 distributed kits
Distribution Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OCC and Original Applicant = IQUUM INC
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