Agency classClass IIOur severity:High FDA (Devices)·Z-0385-2014·Announced 2013-12-04

Roche Recalls ACCU-CHEK Aviva Combo Blood Glucose Meters

Roche is recalling 6,595 ACCU-CHEK Aviva Combo Blood Glucose Meters due to a software issue that may cause incorrect insulin bolus advice.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a software error could lead to incorrect insulin dosing, posing a risk of harm to patients with insulin-requiring diabetes, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 6,595 units of the ACCU-CHEK Aviva Combo Blood Glucose Meter, which is part of the ACCU-CHEK Aviva Combo System. The 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. The affected units were distributed nationwide.

The recall is due to a software synchronization issue. In rare cases, when the Manual Pump option is chosen on the meter, there is a possibility of receiving an incorrect bolus advice recommendation. This error may cause a temporary under-delivery of insulin.

Consumers should stop using the affected meters and contact Roche Diagnostics Operations, Inc. for further instructions. The affected products are identified by the following codes: 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.

The recalled product

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.
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — Blood Glucose Meter
Hazard: incorrect-dosing
software-error
Affected units: 6,595

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

05458544001 and Accu-Chek Combo Kit mg US/Spanish version
05504686001.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Roche Diagnostics Operations, Inc.

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