FDAClass IIJune 30, 2021

Accu-chek Smartview 100 Test Strips recall

ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862

Why was Accu-chek Smartview 100 Test Strips recalled?

Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

NDC/UPC: 365702493100 All lots shipped from 2/23/201 to 3/10/2021

Product
ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
Recalling firm
Cardinal Health Inc.
Quantity
537 boxes of 100 strips
Distribution
US Nationwide distribution in the states of FL, GA, SC.
Recall date
June 30, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls