Drug recall
The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a…
FDA recall event 94993 · Class II · Ortho-Clinical Diagnostics, Inc.
Key facts
| Event ID | 94993 |
|---|---|
| Recall numbers | Z-2684-2024 |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Product type | Devices |
| Products | The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem of the VITROS XT… |
| Initiation date | Jul 10, 2024 |
| Report date | Aug 28, 2024 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 1000136573 |
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: