Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall cobas Liat Analyzer

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall cobas Liat Analyzer see related information
Date Initiated by Firm May 09, 2016
Create Date July 15, 2016
Recall Status1 Terminated 3 on March 24, 2021
Recall Number Z-2216-2016
Recall Event ID 74094
510(K)Number K111387  
Product Classification Respiratory virus panel nucleic acid assay system - Product Code OCC
Product cobas¿ Liat¿ Analyzer
Code Information US-IVD: M1-E-00383 & M1-E-00434
Recalling Firm/
Manufacturer		 Roche Molecular Systems, Inc.
1080 US Highway 202 S
Branchburg NJ 08876-3733
For Additional Information Contact
908-253-7200
Manufacturer Reason
for Recall		 Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers were notified of the recall via phone and email sent on 5/9/2016. They were instructed to take the following actions: Immediately discontinue use of the affected instruments until they have been reworked by a Roche Field Engineering Specialist. A Roche representative will contact you to schedule this service. Complete the attached fax form and fax it to 1-317-521-4815. File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center 1-800-800-5973 if you have questions.
Quantity in Commerce 2
Distribution Distributed in NC and WA.
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
-
-