Tucson, AZ, United States
Accelerate Diagnostics Inc recalls
3 recalls recorded since 2018, most recently on 17 October 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 October 2022
- Reason
- Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.
- Distribution
- U.S.: AR, CA, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, MT, NC, ND, NJ, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV. O.U.S.: Germany, Italy, Kuwait, Latvia, Poland, Portugal, Romania, Saudi Arabia, Spain, and United Arab Emirates
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0345-2023, Z-0346-2023
- Accelerate PhenoTest BC kit REF 10101018
- Accelerate PhenoTest BC kit REF 10102018
Terminated Class II Medical devices
- Recall started
- 14 March 2018
- Terminated
- 17 January 2023
- Reason
- The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
- Distribution
- Distributed to IL, TX, CA, SC, and DE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1529-2018
- Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
Terminated Class II Medical devices
- Recall started
- 13 March 2017
- Terminated
- 21 May 2021
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1065-2019
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.