FDAClass IIOctober 9, 2019

Accu-Chek Aviva II Meter - Product Usage: a. The recall

Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative…

Why was Accu-Chek Aviva II Meter - Product Usage: a. The recalled?

Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).

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?

Serial numbers between xxx20000000 and xxx23284925, or less than xxx06335297 Updated serial numbers on 10/12/2019: Aviva II: Between XXX20000000 and XXX23284925 Updated 10/18/2019: Aviva II from XXX05000001 to XXX06335297 OR from XXX20000000 to XXX23284925

Product
Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative…
Recalling firm
Roche Diabetes Care, Inc.
Quantity
26,600
Distribution
Worldwide distribution - US Nationwide distribution.
Recall date
October 9, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls