FDA Device Recall Z-0183-2022

ELLUME LTD · East Brisbane, N/A

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Ellume COVID-19 Home Test

Lot / serial / GTIN: 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: 427,994 kits

Reason for recall

Due to a higher rate of false positive test results.

Recall record

Recall number: Z-0183-2022
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
Recall initiated: 2021-10-01
Classified by FDA Center: 2021-11-10
FDA published: 2021-11-17
Recalling firm: ELLUME LTD
Firm location: East Brisbane, N/A, Australia

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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