Recall Z-0452-2022 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Biomeme, Inc.
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
| Date | Oct 20, 2021 |
| Status | Terminated |
| 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). |
| Root cause | Incorrect or no expiration date |
| Action | On October 20, 2021, the firm sent an informal notice to customers titled "Product Update: Storing your RNA Process Control (RPC)". On November 4, 2021, the firm followed up with a formal notice titled "Medical Device Correction". The letter notified customers of the need to shorten the life of the RPC Buffer once resuspended from one week to TWO DAYS while stored at room temperature (15 degrees Celsius - 30 degrees Celsius). Actions to be taken by the Customer: Effective immediately, users of resuspended RPC Buffer should discard after two days when stored at room temperature. For longer-te |
| Quantity | 11,607 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.