Agency classClass IIOur severity:High FDA (Devices)·Z-2185-2018·Announced 2018-06-20

Roche Recalls Accu-Chek Aviva Plus Test Strips Due to Potential Errors

Roche Diabetes Care is recalling specific lots of Accu-Chek Aviva Plus test strips because they may produce biased results or fail to detect blood, potentially leading to incorrect user actions.

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 is classified as FDA Class II. The hazard involves a medical device that may provide inaccurate data, leading to incorrect user actions, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Roche Diabetes Care, Inc. is recalling four US lots of Accu-Chek Aviva Plus Test Strips. The affected catalog numbers are 06908217001, 06908268001, and 06908349001. The specific lot numbers involved are 496947, 497291, 497296, and 497325. The recall covers 295 and 248 units, which were distributed nationwide in the US and to numerous foreign countries.

The recalling firm identified that these test strips are out of specification. Affected strips show an increased potential for errors prior to applying blood, may not be detected once inserted, or may produce biased results that are not detectable. If a biased result occurs, users might take incorrect actions based on the displayed blood glucose reading.

Consumers should check their test strips for the affected lot numbers and stop using them if they match. The source text does not specify a particular consumer action such as returning the product or seeking a refund, but implies the need to avoid using the defective strips to prevent incorrect medical decisions.

The recalled product

Product: Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose…
Manufacturer: Roche Diabetes Care, Inc.
Category: Medical Device — Blood Glucose Monitoring
Hazard: inaccurate-reading
device-error

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 (4)

Lots 496947
497291
497296
497325

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Roche Diabetes Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Roche Diabetes Care, Inc.

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