Positive Blood Culture Identification And Ast Kit

Accelerate PhenoTest BC kit REF 10101018

Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.

Accelerate PhenoTest BC kit REF 10102018

Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.

Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B

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 mitigate any risk associated with these rare isolates, the firm has implemented an Expert Rule that suppresses the meropenem result for isolates that display a profile consistent with those that generated a false-susceptible result. The firm has responded to this risk by implementing a set of suppression rules, in a software update, to prevent incorrect results.

Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ.

The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).