Drug recall
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number…
FDA recall event 85363 · Class II · Ortho-Clinical Diagnostics
Key facts
| Event ID | 85363 |
|---|---|
| Recall numbers | Z-1930-2020, Z-1931-2020 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Product type | Devices |
| Products | VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine…, VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results. |
| Initiation date | Apr 1, 2020 |
| Report date | May 20, 2020 |
| Termination date | Jan 19, 2021 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 1000305840 |
At a glance
- 1–9 Products in this recall
- 1–9 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: