Biomeme, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0452-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 20, 2021

Date Posted: January 12, 2022

Recall Number: Z-0452-2022

Event ID: 89064

Reason for Recall:

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).

Status: Terminated

Product Quantity: 11,607

Code Information:

All lots. Last lot of Kit distributed with the old IFU is 20210914.

Distribution Pattern:

Domestic distribution to AZ, CA, FL, HI, IN, KY, MD, MO, NC, NJ, NY, OH, OK, PA, TX, VA. Foreign distribution to Ghana, Dominican Republic, and Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated