Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Accelerate Pheno system Recalled by Accelerate Diagnostics Inc Due to Rare isolates of Enterobacteriaceae may generate a susceptible...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Accelerate Diagnostics Inc directly.
Affected Products
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.
Quantity: 81
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Accelerate Diagnostics Inc
Accelerate Diagnostics Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report