Recall Z-0345-2023— Accelerate Diagnostics Inc

Name: FDA recall Z-0345-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-17

Class II · Ongoing

Class II FDA medical device recall by Accelerate Diagnostics Inc, initiated 2022-10-17. It names one FDA 510(k) clearance: K192665. Product: Accelerate PhenoTest BC kit REF 10101018. 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..

Recalling firm: Accelerate Diagnostics Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-10-17
Firm location: Tucson, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K192665 — Accelerate Pheno System, Accelerate PhenoTest BC KitAccelerate Diagnostics, Inc.·cleared 2020-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Accelerate PhenoTest BC kit REF 10101018

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.