Ellume COVID-19 Home Test
Reported: November 17, 2021 Initiated: October 1, 2021 #Z-0183-2022
Product Description
Ellume COVID-19 Home Test
Reason for Recall
Due to a higher rate of false positive test results.
Details
- Recalling Firm
- ELLUME LTD
- Units Affected
- 427,994 kits
- Distribution
- U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
- Location
- East Brisbane, N/A
Frequently Asked Questions
What product was recalled? ▼
Ellume COVID-19 Home Test. Recalled by ELLUME LTD. Units affected: 427,994 kits.
Why was this product recalled? ▼
Due to a higher rate of false positive test results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 17, 2021. Severity: Critical. Recall number: Z-0183-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11