Home / Recalls / Biomeme, Inc. / Z-0452-2022

Z-0452-2022 Class II Terminated

Recalled by Biomeme, Inc. — Philadelphia, PA

Recall Details

Product Type: Devices
Report Date: January 12, 2022
Initiation Date: October 20, 2021
Termination Date: March 5, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11,607

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

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).

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.

Code Information

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