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U.S. Department of Health and Human Services

Class 2 Device Recall Accelerate PhenoTest" BC kit

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  Class 2 Device Recall Accelerate PhenoTest" BC kit see related information
Date Initiated by Firm October 17, 2022
Date Posted December 06, 2022
Recall Status1 Open3, Classified
Recall Number Z-0345-2023
Recall Event ID 91075
510(K)Number K192665  
Product Classification Positive blood culture identification and AST kit - Product Code PRH
Product Accelerate PhenoTest BC kit REF 10101018
Code Information Part Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A
Recalling Firm/
Manufacturer		 Accelerate Diagnostics Inc
3950 S Country Club Rd Ste 470
Tucson AZ 85714-2240
For Additional Information Contact Kurtis Montegna
520-260-6610
Manufacturer 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.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action 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
Quantity in Commerce 200 kits
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PRH and Original Applicant = Accelerate Diagnostics, Inc.
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