Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Summary
The FDA issued a Class II for Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 072 by Roche Diabetes Care, Inc.. Reason: Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the s.
Details
Source
Device Recall
External ID
Z-2352-2021
Action Date
2021-09-01
Status
Ongoing
Category
device
Product Description
Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Lot/Code Info: Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
Quantity Affected: 146,854 (US); 59,815,555 (OUS)
Reason for Recall
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
Distribution
Worldwide distribution - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-28
Company
Indianapolis, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Roche Diabetes Care, Inc. has 13 FDA actions in our database, including 6 recalls and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Roche Diabetes Care, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Roche Diabetes Care, Inc. have FDA actions?
Roche Diabetes Care, Inc. has 13 FDA actions in our database, including 6 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2352-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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