Summary
The FDA issued a Class I for Ellume COVID-19 Home Test by ELLUME LTD. Reason: Due to a higher rate of false positive test results..
Details
Source
Device Recall
External ID
Z-0183-2022
Action Date
2021-11-17
Status
Ongoing
Category
device
Product Description
Ellume COVID-19 Home Test
Lot/Code Info: Catalogue number I-SRS-C-01 Master Lot Numbers: 21047-4; 21047-5; 21089-1; 21117-1; PF06Z-H; 21099-1; 21124-1; 21125-1; PF03X-H; PF057-H; PF05W-H; PF069-H; PF06E-H; PF06N-H; PF06Z-H; PG080-H; PG08H-H; PH08X-H;
Quantity Affected: 427,994 kits
Reason for Recall
Due to a higher rate of false positive test results.
Distribution
U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-01
Company
East Brisbane, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 102 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (ELLUME LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ELLUME LTD have FDA actions?
This is the only FDA action we have on record for ELLUME LTD in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0183-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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