Accelerate Diagnostics Inc recalls Accelerate PhenoTest BC kit REF 10101018

Recall date

October 17, 2022

Source

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

Recall number

Z-0345-2023

FDA classification

Class II

Brand / firm

Accelerate Diagnostics Inc

Sold / distributed

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

Why it was recalled

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.

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 PhenoTest BC kit REF 10101018