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Recall Observatory FDA recall evidence

Device product

Accelerate PhenoTest BC kit REF 10101018

Z-0345-2023

October 17, 2022

Class II

Product summary

Firm
Accelerate Diagnostics Inc
Event
Event 91075
Status
Ongoing
Classification
Class II
Quantity
200 kits
Official record key
device-enforcement:Z-0345-2023

Official wording

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.

Code information: Part Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.