Drug recall
Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The…
FDA recall event 82216 · Class II · Accelerate Diagnostics Inc
Key facts
| Event ID | 82216 |
|---|---|
| Recall numbers | Z-1065-2019 |
| Recalling firm | Accelerate Diagnostics Inc |
| Product type | Devices |
| Products | Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant result by broth microdilution. In order to… |
| Initiation date | Mar 13, 2017 |
| Report date | Apr 3, 2019 |
| Termination date | May 21, 2021 |
| City | Tucson |
| State | AZ |
| Country | United States |
| FEI number | 3010671651 |
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: