Biomeme, Inc. Recall 89064
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
Biomeme, Inc. Recall 89064 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0452-2022 |
| Event ID | 89064 |
| Event 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 Type | Devices |
| 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. |
| Quantity | 11,607 |
| Recall 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). |
| Device Classification | 20220112 |
| Device Code Info | All lots. Last lot of Kit distributed with the old IFU is 20210914. |
| Center Classification Date | 20220104 |
| Recall Initiation Date | 20211020 |
| Recalling Firm | Biomeme, Inc. |
| Initial Notification | Letter |
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