Z-0385-2014Class II

ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK...

Name: Z-0385-2014 ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK...
Creator: Roche Diagnostics Operations, Inc.
Published: 2013-10-25
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2013-10-25 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of... on 2013-10-25. FDA classified it as Class II and gives the reason as "There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when the Manual Pump option is chosen on the ACCU-CHEK Aviva Combo meter, there is a possibility of receiving an incorrect bolus...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0385-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-25
Posted: 2013-11-22
Terminated: 2015-01-14
Recalling firm: Roche Diagnostics GmbH
Product: ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when the Manual Pump option is chosen on the ACCU-CHEK Aviva Combo meter, there is a possibility of receiving an incorrect bolus advice recommendation that may cause a temporary under delivery of insulin.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Roche Diagnostics, sent an "URGENT MEDICAL DEVICE CORRECTION (UMDC)" letter dated October 29, 2013, via UPS to their consignees/customers. The letter described the product, problem and actions to be taken. The UMDC informed them of the software synchronization issue with the ACCU-CHEK Combo system that may cause a temporary under delivery of insulin. The customers were instructed to ensure they properly deliver the correction bolus when utilizing the Manual Pump option, as instructed in the Owners Booklet; and complete and return the Business Reply Card via fax to 1-877-282-0223. The Distributors were instructed to provide the UMDC to their direct customers. The HCPs were instructed to remind their patients to follow the instructions in the Accu-Chek Aviva Combo Meter Advanced Owners Booklet when utilizing Manual Pump option. Questions about the information contained in this UMDC are directed to ACCU-CHEK Pump Support, 24 hours a day, seven days a week at 1-800-688-4578.
Quantity in commerce: 6,595 units
Distribution: Nationwide Distribution.
Product codes and lots: AccuChek Aviva Combo meter 05075645005 packaged in Accu-Chek Combo Kit mg US/English version, 05458544001 and Accu-Chek Combo Kit mg US/Spanish version, 05504686001.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0385-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0385-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-22

Product code NBW

K111353Class IIAccu-Check Combo SystemRoche Diagnostics / cleared 2012-07-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)