Accelerate PhenoTest BC kit REF 10101018 recall — FDA Z-0345-2023
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and…
Overview of recall records associated with Accelerate Diagnostics Inc., including dates, categories and classifications where available.
Classification mix: Class II: 4.
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and…
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and…
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…
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
This page summarizes recall records in which the official source identifies Accelerate Diagnostics Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.