Drug recall
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100…
FDA recall event 76374 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 76374 |
|---|---|
| Recall numbers | Z-1384-2017 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results. |
| Initiation date | Jan 30, 2017 |
| Report date | Mar 8, 2017 |
| Termination date | Aug 19, 2017 |
| City | Brea |
| State | CA |
| Country | United States |
| FEI number | 2050012 |
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: