medical Class II Updated 2022-01-12

Biomeme, Inc. recalls Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for

Recalled Product

Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564

Hazard / Issue

The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stored at room temperature. Ongoing stability studies have indicated the need to shorten the life of the RPC Buffer once resuspended from the current instruction of one week to two days when stored at room temperature (15degC-30degC).

Issued by

FDA

Affected States: AZ, CA, FL, HI, IN, KY, MD, MO, NC, NJ, NY, OH, OK, PA, TX, VA
Lot/Code Info: All lots. Last lot of Kit distributed with the old IFU is 20210914.
View official government recall

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