FDAClass IIFebruary 12, 2020

ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood recall

ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020

Why was ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 498287

Product
ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
Recalling firm
Roche Diabetes Care, Inc.
Quantity
61,329 units (OUS)
Distribution
Nationwide: Foreign: Austalia, India
Recall date
February 12, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls