Summary
The FDA issued a Class II for Detect Covid-19 Test Product/Model Number: 21205 by Detect Headquarters. Reason: There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result in.
Details
Source
Device Recall
External ID
Z-0879-2023
Action Date
2023-01-11
Status
Ongoing
Category
device
Product Description
Detect Covid-19 Test Product/Model Number: 21205
Lot/Code Info: HY263, HY264, and HB264 Expiration 01JAN2023
Quantity Affected: 10142 (US); 960 OUS
Reason for Recall
There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.
Distribution
Domestic distribution nationwide. Foreign distribution to Hong Kong.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-08
Company
Guilford, CT
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 162 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 (Detect Headquarters) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Detect Headquarters have FDA actions?
This is the only FDA action we have on record for Detect Headquarters in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0879-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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