Drug recall
Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or…
FDA recall event 87561 · Class II · Medline Industries Inc
Key facts
| Event ID | 87561 |
|---|---|
| Recall numbers | Z-1407-2021 |
| Recalling firm | Medline Industries Inc |
| Product type | Devices |
| Products | Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Possible false negative or false positive results due to the product being compromised during shipment. |
| Initiation date | Mar 15, 2021 |
| Report date | Apr 21, 2021 |
| City | Northfield |
| State | IL |
| Country | United States |
| FEI number | 1417592 |
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: