Drug recall
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
FDA recall event 84866 · Class II · Abbott Diabetes Care, Inc.
Key facts
| Event ID | 84866 |
|---|---|
| Recall numbers | Z-1556-2020, Z-1557-2020, Z-1558-2020 |
| Recalling firm | Abbott Diabetes Care, Inc. |
| Product type | Devices |
| Products | FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810, Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653, Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for… |
| Initiation date | Nov 14, 2019 |
| Report date | Apr 1, 2020 |
| Termination date | Apr 28, 2021 |
| City | Alameda |
| State | CA |
| Country | United States |
| FEI number | 3002803444 |
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: