Drug recall
BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality…
FDA recall event 79993 · Class II · bioMerieux, Inc.
Key facts
| Event ID | 79993 |
|---|---|
| Recall numbers | Z-2428-2018, Z-2429-2018 |
| Recalling firm | bioMerieux, Inc. |
| Product type | Devices |
| Products | BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal…, BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay… |
| Initiation date | Jan 4, 2018 |
| Report date | Jul 18, 2018 |
| Termination date | Apr 14, 2022 |
| City | Durham |
| State | NC |
| Country | United States |
| FEI number | 3002769706 |
At a glance
- 1–9 Products in this recall
- 10–99 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: