Z-0998-2020Class II

Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number...

Name: Z-0998-2020 Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number...
Creator: Roche Diabetes Care, Inc.
Published: 2019-12-11
License: https://open.fda.gov/license/

Roche Diabetes Care, Inc. / initiated 2019-12-11 / Terminated / root cause: manufacturing process

FDA source

Roche Diabetes Care, Inc. began a recall of Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001 on 2019-12-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0998-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-11
Posted: 2020-02-05
Terminated: 2022-07-08
Recalling firm: Roche Diabetes Care, Inc.
Product: Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
Product code: NBW System, Test, Blood Glucose, Over The Counter
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
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 92,836 vials
Distribution: Nationwide: Foreign: Austalia, India
Product codes and lots: Lot Number:498315 NDC: 65702-0407-10 UPC: 3-65702-40710-7

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0998-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0997-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-0998-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-0999-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05

Product code NBW

K131029Class IIAccu-Chek Aviva Plus Test StripRoche Diagnostics Operations, Inc. / cleared 2013-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)