Drug recall
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A., UDI…
FDA recall event 84909 · Class II · The Binding Site Group, Ltd.
Key facts
| Event ID | 84909 |
|---|---|
| Recall numbers | Z-1500-2020 |
| Recalling firm | The Binding Site Group, Ltd. |
| Product type | Devices |
| Products | Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which… |
| Initiation date | Nov 6, 2019 |
| Report date | Mar 25, 2020 |
| Termination date | Sep 8, 2022 |
| City | Birmingham |
| Country | United Kingdom |
| FEI number | 3002808340 |
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: