Accelerate Diagnostics Inc FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Accelerate PhenoTest BC kit REF 10102018Class IIOct 17, 2022Due improperly formulated and released bulk lot of fluoresce	Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting	Class IIDevices	Oct 17, 2022
Accelerate PhenoTest BC kit REF 10101018Class IIOct 17, 2022Due improperly formulated and released bulk lot of fluoresce	Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting	Class IIDevices	Oct 17, 2022