Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Summary
The FDA issued a Class II for Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked by Acon Biotech (Hangzhou) Co., Ltd.. Reason: Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test resu.
Details
Source
Device Recall
External ID
Z-0945-2022
Action Date
2022-04-27
Status
Ongoing
Category
device
Product Description
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Lot/Code Info: Lots: COV1080201, COV1105014
Quantity Affected: 303,760
Reason for Recall
Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results.
Distribution
US: MD, PA International Distribution to countries of: Hungary and China.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-09
Company
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 150 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Acon Biotech (Hangzhou) Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Acon Biotech (Hangzhou) Co., Ltd. have FDA actions?
This is the only FDA action we have on record for Acon Biotech (Hangzhou) Co., Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0945-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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