Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Biomeme SARS-CoV-2- Real Time RT-PCR Test Recalled by Biomeme, Inc. Due to The current IFU specifies a shelf-life of one...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biomeme, Inc. directly.
Affected Products
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
Quantity: 11,607
Why Was This Recalled?
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).
Where Was This Sold?
This product was distributed to 16 states: AZ, CA, FL, HI, IN, KY, MD, MO, NJ, NY, NC, OH, OK, PA, TX, VA
About Biomeme, Inc.
Biomeme, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report