Reported Apr 3, 2019 · Terminated
Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate…
Accelerate Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accelerate Diagnostics Inc · 3950 S Country Club Rd Ste 470 · Tucson, AZ · 85714-2240
Is this the product you have?
- Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1
- PSW000012B Product UsageThe 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
- Lot codes and dates
- REF10401008
- Serial Numbers
81 of 81 codes
132413251431143210841087136713621363161516161358135914531354135715991176117813531356157615771578132213231454159415981288129016881690169116941798179918001801113511511326132714771478147914801619162016171618148915011687157315741144114512471249
- Amount recalled
- 81
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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