Events

Recall of Drew Scientific DREW 3PAC Reagent Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by JAS 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
    77464
  • Event Risk Class
    Class 2
  • Event Number
    Z-2656-2017
  • Event Initiated Date
    2017-04-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156089
  • 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
    May result in elevated platelet backgrounds during routine startup/background checks.
  • Action
    The firm sent notification of recall to consignees on 04/21/2017 by mail in domestic states, and by email or mail to foreign consignees. The notification informed consignees of the product removal. it instructed consignees to discontinue use, destroy product on hand, complete the product destruction form, and contact the firm's customer service department (305-324-2300 or 800-433-0945) to request product replacement.

Device

Drew Scientific DREW 3PAC Reagent Kit
  • Model / Serial
    Lot # 0868 Exp. Date 11/28/2018,  Lot # 0869 & Lot 0870 Exp. Date 01/10/2019,  Lot # 0871,0872, 0873, 0874 , 0875, and 0876 Exp. Date 02/06/2019, and  Lot # 0877, 0877, 0879, 0880, 0881, and 0882 Exp. Date 02/23/2019
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AR, CA, FL, GA, IA, IN, LA, MA, MN, MO, NC, NE, NY, SC, TN, TX, and Puerto Rico United Arab Emirates, Bolivia, Republic of C¿te dIvoire, Colombia, Costa Rica, Ecuador, Egypt, Indonesia, Iraq, Italy, Korea, Mexico, Russia, Philippines, Slovenia, Tunisia, Venezuela, and Vietnam
  • Product Description
    Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
  • Manufacturer
    JAS Diagnostics Inc.

Manufacturer

JAS Diagnostics Inc.
  • Manufacturer Address
    JAS Diagnostics Inc., 14100 NW 57th Ct, Miami Lakes FL 33014-3107
  • Source
    USFDA