Recall Z-0452-2022— Biomeme, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomeme, Inc., initiated 2021-10-20, terminated 2024-03-05. FDA's recall record names no specific 510(k) clearance for this event. 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. 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)..
- Recalling firm
- Biomeme, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-10-20
- Terminated
- 2024-03-05
- Firm location
- Philadelphia, PA, United States
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.