Biomeme SARS-CoV-2- Real Time RT-PCR Test — Class II medical device recall Z-0452-2022
Terminated recall by Biomeme, Inc., reported 2022-01-12, distributed in AZ, CA, FL, HI, IN, KY, MD, MO…. The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stored at room te
| Recall number | Z-0452-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomeme, Inc., Philadelphia, PA, United States |
| Recall initiated | 2021-10-20 |
| Classified | 2022-01-04 |
| Reported by FDA | 2022-01-12 |
| Terminated | 2024-03-05 |
| Distributed | AZ, CA, FL, HI, IN, KY, MD, MO, NC, NJ, NY, OH, OK, PA, TX, VA |
| Countries outside the US | DO, GH, SG |
| Quantity | 11,607 |
| Reason classes | specification failure |
| Model numbers | 100002824 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0452-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.