Roche Diabetes Care, Inc. recalls Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06…

Recall date

May 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2185-2018

FDA classification

Class II

Brand / firm

Roche Diabetes Care, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala H…

Why it was recalled

The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detected once inserted, or biased results, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.