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Accelerate Diagnostics Recalls
4 recalls on record · May 2, 2018 to December 7, 2022 · Medical Devices
Recalls by year
18
19
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 7, 2022Medical DevicesFDA
Accelerate Diagnostics Inc recalls Accelerate PhenoTest BC kit REF 10102018
Hazard: 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.
December 7, 2022Medical DevicesFDA
Accelerate Diagnostics Inc recalls Accelerate PhenoTest BC kit REF 10101018
Hazard: 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.
April 3, 2019Medical DevicesFDA
Accelerate Diagnostics Inc recalls Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelera
Hazard: 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.
May 2, 2018Medical DevicesFDA
Accelerate Diagnostics Inc recalls Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A mult
Hazard: The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).