# FDA recall Z-1065-2019

> **Accelerate Diagnostics Inc** · Class II · device recall initiated 2017-03-13.

## Product

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.

## Reason for recall

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.

## Distribution

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

## Key facts

- **Recall number:** Z-1065-2019
- **Recalling firm:** Accelerate Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-03-13
- **Report date:** 2019-04-03
- **Termination date:** 2021-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tucson, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1065-2019

## Citation

> AI Analytics. FDA recall Z-1065-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1065-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*