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 Roche Diagnostics COBAS Elecsys AntiTPO

  • 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 Roche Diagnostics COBAS Elecsys AntiTPO see related information
Date Initiated by Firm August 20, 2020
Create Date September 17, 2020
Recall Status1 Terminated 3 on October 22, 2021
Recall Number Z-2981-2020
Recall Event ID 86319
510(K)Number K051890  
Product Classification System, test, thyroid autoantibody - Product Code JZO
Product Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Code Information All current and upcoming lots
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
Manufacturer Reason
for Recall		 Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Urgent Medical Device Correction notification letters dated 8/20/20 were distributed to customers. Actions Required " Be aware of the new RF interference claims listed in this Urgent Medical Device Correction (UMDC). This UMDC serves as labeling until the updated method sheet (V3), anticipated in September 2020, is available. " Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. Customers do not need to perform an additional RF test unless otherwise determined in consultation with the physician or pathologist at your facility. " Complete the attached fax back form (TP-01048) and fax or email it according to the instructions on the form. " File this UMDC for future reference. Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. The Elecsys Anti-TPO method sheet is being updated with the new claim for Rheumatoid Factor (RF) interference. Until the updated method sheet (V3) is available, this Urgent Medical Device Correction serves as your labeling. When these method sheets are updated, they will be available on the diagnostics.roche.com website and on the cobas¿ e-library. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
Quantity in Commerce 11,870 reagent kits
Distribution US Nationwide
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 = JZO and Original Applicant = ROCHE DIAGNOSTICS CORP.
-
-