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Accelerate Diagnostics Inc Recall 91075

Description: Accelerate PhenoTest BC kit REF 10101018

Accelerate Diagnostics Inc Recall 91075 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0345-2023
Event ID91075
Event DescriptionAccelerate PhenoTest BC kit REF 10101018
Product TypeDevices
DistributionU.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
Quantity200 kits
Recall ReasonDue 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.
Device Classification20221207
Device Code InfoPart Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A
Center Classification Date20221130
Recall Initiation Date20221017
Recalling FirmAccelerate Diagnostics Inc
Initial Notification Other
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