Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
FDA Recall Z-0998-2020 · Posted None
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Recalling FirmRoche Diabetes Care, Inc.
Recall StatusTerminated
Product CodeNBW
Date Initiated2019-12-11
Date Terminated2022-07-08
Product Quantity92,836 vials
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
Firm Action
Roche 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 [email protected] 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.
Root Cause
Process control
Distribution Pattern
Nationwide: Foreign: Austalia, India
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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