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Class 2 Device Recall Accelerate PhenoTest" BC kit |
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Date Initiated by Firm |
October 17, 2022 |
Date Posted |
December 06, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0346-2023 |
Recall Event ID |
91075 |
510(K)Number |
K192665
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Product Classification |
Positive blood culture identification and AST kit - Product Code PRH
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Product |
Accelerate PhenoTest BC kit REF 10102018
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Code Information |
Part Number: 10102018
UDI-DI Code: 00862011000369
Lot Numbers:
5559A
5556A
5555A
5554A
5553A
5551A
5550A
5548A
5546A
5557A
5558A
5560A
5561A
5562A
5563A
5564A
5567A
5568A
5570A
5571A
5572A
5574A
5578A
5579A
5580A
5583A
5577A
5576A
5581A
5582A
5585A
5586A
5587A
5589A
5590A
5591A
5592A
5594A
5595A
5596A
5597A
5598A
5599A
5601A
5602A
5603A
5604A
5607A
5608A
5610A
5611A
5613A
5614A
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Recalling Firm/ Manufacturer |
Accelerate Diagnostics Inc 3950 S Country Club Rd Ste 470 Tucson AZ 85714-2240
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For Additional Information Contact |
Kurtis Montegna 520-260-6610
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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.
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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 |
7,160 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
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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.
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510(K) Database |
510(K)s with Product Code = PRH and Original Applicant = Accelerate Diagnostics, Inc.
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