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U.S. Department of Health and Human Services

Class 2 Device Recall cobas SARSCoV2 & Influenza A/B Test

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  Class 2 Device Recall cobas SARSCoV2 & Influenza A/B Test see related information
Date Initiated by Firm August 04, 2021
Create Date September 21, 2021
Recall Status1 Terminated 3 on February 23, 2024
Recall Number Z-2498-2021
Recall Event ID 88600
Product Classification COVID-19 multi-analyte respiratory panel nucleic acid devices - Product Code QLT
Product cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Code Information Lot 10119Z
Recalling Firm/
Manufacturer		 Roche Molecular Systems, Inc.
1080 US Highway 202 S
Branchburg NJ 08876-3733
For Additional Information Contact Roche Support Network Customer Support Center
800-800-5973
Manufacturer Reason
for Recall		 Customers have reported an increased number of false positive SARS-CoV-2 results.
FDA Determined
Cause 2		 Under Investigation by firm
Action On August 4, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were instructed to take the following actions: - Immediately discontinue the use of the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat system, lot number 10119Z. - For handling previous positive results generated with the cobas SARS-CoV-2 & Influenza A/B test for use on the cobas Liat system, follow your laboratory s standard operating procedures to investigate the potential for false positive results. Please consult with the physician or clinicians at your facility to determine specific clinical implications for your patients. - Repeat testing can be performed using other cobas SARS-CoV-2 & Influenza A/B lot numbers. - Complete all sections of the enclosed faxback form and fax it to 1-888-312-5960 or email it to Roche4691@stericycle.com. - Discard lot number 10119Z according to your local waste management ordinance. - File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-800-5973 if you have questions about this recall.
Quantity in Commerce 211 kits (US); 3073 kits (OUS)
Distribution Worldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovakia, and Spain.
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.
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