Accelerate Diagnostics Inc Accelerate PhenoTest BC kit REF 10101018 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Accelerate PhenoTest BC kit REF 10101018
Brand
Accelerate Diagnostics Inc
Lot Codes / Batch Numbers
Part Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A
Products Sold
Part Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A
Accelerate Diagnostics Inc is recalling Accelerate PhenoTest BC kit REF 10101018 due to Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 11/04/2022, the firm communicated an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that the firm has become aware of complaints concerning false positive identification results for Staphylococcus aureus and Streptococcus spp. when using the Accerlerate PhenoTest BC kits. Customer are instructed to: (1) Share this customer notification with all who need to be made aware within their organization. (2) Appropriately destroy all affected Accelerate PhenoTest BC kits by defacing all labeling and disposing in accordance with site biohazard or waste policies and procedure. (3) Complete the Recall Response Form and return it to Accelerate Diagnostics. (4) Retrospectively review runs from affected lots, specifically those runs with positive identification results for either Staphylococcus aureus or Streptococcus spp. Follow their institutional policies and processes to review prior patient results related to the described issue. (5) Continue to report all technical issues through Accelerate Technical Support. Contact for Questions: NA Customer Service & Technical Support Toll free: +1 (888) 586 2939 opt. 4 Direct: +1 (520) 365 3100 Email: support@axdx.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CA, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MN, MS, MO, MT, NJ, NY, NC, ND, OH, PA, RI, SC, TN, TX, VA, WA, WV, DC
Page updated: Jan 10, 2026