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 The AccuChek Aviva Plus Test Strips

  • 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 The AccuChek Aviva Plus Test Stripssee related information
Date Initiated by FirmDecember 11, 2019
Create DateFebruary 05, 2020
Recall Status1 Terminated 3 on July 08, 2022
Recall NumberZ-0998-2020
Recall Event ID 84518
510(K)NumberK131029 
Product Classification System, test, blood glucose, over the counter - Product Code NBW
ProductAccu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
Code Information Lot Number:498315  NDC: 65702-0407-10 UPC: 3-65702-40710-7  
Recalling Firm/
Manufacturer		 Roche Diabetes Care, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactAmy Lynn
317-521-0251
Manufacturer Reason
for Recall		Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
FDA Determined
Cause 2		Process control
ActionRoche Diabetes Care issued Urgent Medical Device Corrections via UPS Ground mail to the patients and distributors on 12/11/2019. Letter states reason for recall, health risk and action to take: Immediately discontinue using test strip lots 497864 and 498315. Affected test strips must be discarded. To get replacement test strips, or for questions regarding this notification, use one of the following options: For fastest replacement of your product, please submit your request at https://notices.accu-chek.com. Email Accu-Chek Customer Care at accu-chek.care@roche.com and include the following information: your name, full mailing address, phone number, test strip lot number and number of affected test strip vials. o Contact our Accu-Chek Customer Care line at 1-800-358-4866 Monday through Friday between the hours of 8:00 am and 8:00 pm Eastern Standard Time. If a Business Reply Form was included with this notification, please complete and return it by U.S. mail using the provided postage paid envelope. Please keep this notification for future reference. Distributors/Suppliers instructed as follows: Discontinue distribution and destroy any remaining stock of the affected lots (497864 and 498315) immediately. make this notification available to consumer customers to whom you distributed affected product. If you have distributed affected product to other suppliers, provide a copy of this UMDC to those suppliers. Have those customers report the quantity of product destroyed to you.
Quantity in Commerce92,836 vials
DistributionNationwide: Foreign: Austalia, India
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NBW
-
-