Philadelphia, PA, United States
Biomeme, Inc. recalls
3 recalls recorded since 2018, most recently on 20 October 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 20 October 2021
- Terminated
- 5 March 2024
- Reason
- 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
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0452-2022
- 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
Terminated Class III Medical devices
- Recall started
- 5 January 2021
- Terminated
- 11 June 2021
- Reason
- Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results are generated.
- Distribution
- Domestic: FL, TX, IN, KY, OH, NY, CA, PA, MD. Foreign: Canada, Zimbabwe.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0940-2021
- Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR
Terminated Class II Medical devices
- Recall started
- 23 October 2020
- Terminated
- 25 January 2021
- Reason
- The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected amber-to-red co-excitation in the assay.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, IN, NY, OH, PA, and the countries of Canada, Singapore, Zimbabwe, and Dominican Republic.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0513-2021
- The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and p
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.