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Accelerate PhenoTest BC AST QC test
ACCELERATE DIAGNOSTICS, INC. · Model 10106158 · UDI-DI 10862011000342
PRH
Prescription
1
510(k) clearances
4
Adverse events
4
Recalls
0
Facilities
Description
The Accelerate PhenoTest™ BC AST QC test is intended to serve as an external quality control to monitor the accuracy of the antimicrobial susceptibility test (AST) calls made by the Accelerate PhenoTest™ BC kit. This quality control test is run in conjunction with the Accelerate PhenoTest™ BC kit.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-10-17 | Accelerate Diagnostics Inc | Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and |
| 2022-10-17 | Accelerate Diagnostics Inc | Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and |
| 2018-03-14 | Accelerate Diagnostics Inc | The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU). |
| 2017-03-13 | Accelerate Diagnostics Inc | Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant result by broth microdilut |
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