Drug recall
UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The…
FDA recall event 84186 · Class II · Beckman Coulter, Inc.
Key facts
| Event ID | 84186 |
|---|---|
| Recall numbers | Z-0516-2020 |
| Recalling firm | Beckman Coulter, Inc. |
| Product type | Devices |
| Products | UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results… |
| Initiation date | Oct 7, 2019 |
| Report date | Dec 4, 2019 |
| Termination date | Apr 27, 2021 |
| City | Miami |
| State | FL |
| Country | United States |
| FEI number | 3000203293 |
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: