Events

Recall of Device Recall Drew Scientific Inc. D3 Hematology AnalyzerD3 Reagent Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Jas Diagnostics/Drew Scientific.

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
    73650
  • Event Risk Class
    Class 2
  • Event Number
    Z-1576-2016
  • Event Initiated Date
    2016-03-10
  • 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=144664
  • 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
    Counter, differential cell - Product Code GKZ
  • Reason
    The reagent pack may result in elevated platelet background during drew3 hematology analyzer routine check.
  • Action
    JAS Diagnostics/ Drew Scientifics sent an Important Product Advisory letter dated March 10, 2016, to all affected customers. The domestic customers were notified via letter and international customers were notified via email. Customers were instructed to contact Drew Scientific Inc. Customer Service or Technical Service at 1-800-433-0945 for product replacement. The firm suggested a temporary workaround of performing five background runs three times per day in order to ensure background counts are running within specification.

Device

Device Recall Drew Scientific Inc. D3 Hematology AnalyzerD3 Reagent Pack
  • Model / Serial
    Lot # 0825, exp 01/06/2018; Lot # 0826, exp 01/06/2018; Lot # 0827, exp 01/06/2018; Lot # 0828, exp 01/21/2018; Lot # 0829, exp 01/21/2018; Lot # 0830, exp 01/21/2018; Lot # 0831, exp 01/21/2018; and Lot # 0832, exp 01/21/2018.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of : AL, AR, CA, FL, GA, IA, IN, KS, KY, LA, MA, MN, MO, MS, NC, NE, NY, SC, TN, and TX. and to the countries of : Bolivia, Cairo, Columbia, Ecuador, Italy, Moscow, Netherlands, Pakistan, Peru, Slovenia, Spain, and Venezuela.
  • Product Description
    Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
  • Manufacturer
    Jas Diagnostics/Drew Scientific

Manufacturer

Jas Diagnostics/Drew Scientific
  • Manufacturer Address
    Jas Diagnostics/Drew Scientific, 14100 NW 57th Ct, Miami Lakes FL 33014-3107
  • Source
    USFDA