Drug recall
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing…
FDA recall event 77464 · Class II · JAS Diagnostics Inc.
Key facts
| Event ID | 77464 |
|---|---|
| Recall numbers | Z-2656-2017 |
| Recalling firm | JAS Diagnostics Inc. |
| Product type | Devices |
| Products | Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | May result in elevated platelet backgrounds during routine startup/background checks. |
| Initiation date | Apr 21, 2017 |
| Report date | Jul 12, 2017 |
| Termination date | Jan 6, 2020 |
| City | Miami Lakes |
| State | FL |
| Country | United States |
| FEI number | 3003071743 |
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: