Drug recall
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or…
FDA recall event 87153 · Class III · Biomeme, Inc.
Key facts
| Event ID | 87153 |
|---|---|
| Recall numbers | Z-0940-2021 |
| Recalling firm | Biomeme, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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. |
| Initiation date | Jan 5, 2021 |
| Report date | Feb 10, 2021 |
| Termination date | Jun 11, 2021 |
| City | Philadelphia |
| State | PA |
| Country | United States |
| FEI number | 3014117298 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: