Drug recall
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative…
FDA recall event 93167 · Class II · Magellan Diagnostics, Inc.
Key facts
| Event ID | 93167 |
|---|---|
| Recall numbers | Z-0219-2024 |
| Recalling firm | Magellan Diagnostics, Inc. |
| Product type | Devices |
| Products | LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate… |
| Initiation date | Sep 19, 2023 |
| Report date | Nov 15, 2023 |
| City | North Billerica |
| State | MA |
| Country | United States |
| FEI number | 1218996 |
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: