Events

Recall of Device Recall Accelerate PhenoTest BC kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Accelerate Diagnostics Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79631
  • Event Risk Class
    Class 2
  • Event Number
    Z-1529-2018
  • Event Initiated Date
    2018-03-14
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162852
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Positive blood culture identification and AST kit - Product Code PRH
  • Reason
    The kits may produce an elevated rate of false positive calls for the staphylococcus aureus identification probe (sau).
  • Action
    The recalling firm contacted all customers on 3/14/2018 via telephone, and a follow-up e-mail was also sent containing a technical bulletin #TB000079, entitled Product Correction Notice, dated March 14, 2018. The notice identified the affected devices and the reason for the recall. Customers were asked to please discontinue use of and dispose of all remaining kits from the affected lots, and document the disposal by completing the 'Certificate of Kit Disposal.' Replacement kits will be provided.

Device

Device Recall Accelerate PhenoTest BC kit
  • Model / Serial
    Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.
  • Distribution
    Distributed to IL, TX, CA, SC, and DE.
  • Product Description
    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. || A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
  • Manufacturer
    Accelerate Diagnostics Inc

Manufacturer

Accelerate Diagnostics Inc
  • Manufacturer Address
    Accelerate Diagnostics Inc, 3950 S Country Club Rd Ste 470, Tucson AZ 85714-2240
  • Manufacturer Parent Company (2017)
    Accelerate Diagnostics, Inc.
  • Source
    USFDA