Accelerate Diagnostics Inc recalls Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate…

Recall date

March 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1065-2019

FDA classification

Class II

Brand / firm

Accelerate Diagnostics Inc

Sold / distributed

Worldwide Distribution - US Nationwide North America and Middle East US: TX, IL, TN, GA, CA, AR, MD, VA, Washington DC, IA, PA, NY, WA, and MO. OUS (Foreign): UK, Spain, Italy, and Germany

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse dark-field images of immobilized growing bacterial cells when used with Accelerate PhenoTest kits.