Events

Recall of Device Recall DrugCheck

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Express Diagnostics Int'l., 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
    59567
  • Event Risk Class
    Class 2
  • Event Number
    Z-3104-2011
  • Event Initiated Date
    2010-11-01
  • Event Date Posted
    2011-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103114
  • 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
    Alcohol dehydrogenase, specific reagent for ethanol enzyme method - Product Code DIC
  • Reason
    Express diagnostics intl'l inc is recalling drugcheck devices because they were informed via letter from the alcohol test strip manufacturer on october 27, 2010 that the product was not 510 k cleared for in vitro diagnostic use and could not be labeled as such in the us.
  • Action
    Express Diagnostics Intl., Inc. sent an Updated Recall Notice dated November 1, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed if they have open orders of the affected product to contact customer service about their order. Customers were asked to complete and fax the form on page 3 of the document to 507-526-2252. Further shipment of products could not continue until Express Diagnostics received the signed form. For questions regarding this recall call 507-526-3951.

Device

Device Recall DrugCheck
  • Model / Serial
    ITEM CODE LOT # 40900 A900 061610  40901 A901 042310  40901 A901 050310  40901 A901 070610  40901 A901 081710  40901 A901C 072110  40901 A904 042310  30500-A A500 022610  30500-A A500 062910  30575 -A A575 040110  30575-A A575 010510  30575-A A575 040110  30575-A A575 081110  30575-A A575 092010  30575-A A575 122309  30603-A A603 100810  30671-A A671 052410  30671-A A671 091310  30800-A A800 030810  30800-A A800 061610  30800-A A800 080310  30800-A A800 082510  30800-A A800 090210  30802-3A 3A802 033010  30802-3A 3A802 051310  30802-3A 3A802 063010  30802-3A 3A802 073010  30802-3A 3A802 082310  30900-A A900 032310  30900-A A900 051310  30900-A A900 060810  30900-A A900 061610  30900-A A900 071410  30900-A A900 072810  30900-A A900 082410  30900-A A900 100510  30900-A A900 101210  30904-A A904 051710  30950-A A950 052209  30950-A A950 062910  30950-A A950 072110  31102-A A1402 051110  40901C A901C 030310  40901C A901C 051310  40901C A901C 072110  40901C A901C 082310  60410-3A 3A410 040710  60500-A A500 030310  60500-A A500 052810  60500-A A500 060810  60500-A A500 062910  60500-A A500 070910  60500-A A500 092210  60505-A A505 052010  60505-A A505 062910  60524-A A524 112309  60526-A A526 062310  60535-A A535 022310  60535-A A535 070210  60535-A A535 090210  60600-A A600 040110  60600-A A600 050710  60600-A A600 071210  60600-A A600 081310  60602-4A 4A602 042810  60602-4A 4A602 050510  60630-4A 4A630 051110  60630-A A630 080510  60630-A A630 092210  60635-4A 4A635 061610  60640-4A 4A640 041510  60640-4A 4A640 062210  60640-4A 4A640 072110  60640-A A640 071609  60705-4A 4A705 060410  60705-4A 4A705 100510  60709-A A709 120809  60800-6A 6A800 091610  60800-A A800 022610  60800-A A800 060310  60800-A A800 080910  60800-A A800 092210  60801-A A801 062110  60820-A A800 072310  60820-A A820 060110  60820-A A820 062310  60820-A A820 072310  60820-A A820 100510  60903-A A903 052810  60910-A A910 071210  60910-A A910 100610  60921-A A921 100710  60925-A A925 030110  60925-A A925 060110  60925-A A925 080610  60930-A A930 060710  60930-A A930 081110  61020-A A020 032310  61020-A A020 061610  61020-A A020 081310  61023-A A023 051110  61023-A A023 100110  61026-4A 4A026 030310  61026-4A 4A026 090210  61028-3A 3A028 080210  61030-3A 3A030 071210  61030-3A 3A030 081110  61030-3A 3A030 101410  61044-6A 6A044 072810  61052-4A 4A052 072810  61052-4A 4A052 091010  61100-A A100 051310  61100-A A100 062310  61100-A A100 073010  61100-A A100 082510  61204-A A204 050310  61204-A A204 061010  61204-A A204 061610  61204-A A204 092310  61206-4A 4A206 012810  61206-4A 4A206 083010  61206-6A 6A206 051110  61303-A A303 052010  61401-A A401 062110  61401-A A401 070610  61404-A A401 062110  65500-4A 4A500 030510  65500-4A 4A500 050310  65500-4A 4A500 060710  65500-4A 4A500 061510  65500-4A 4A500 062510  65500-4A 4A500 070910  65500-4A 4A500 072810  65500-4A 4A500 100110  70410-4A 4A410 082510  70500-3A 3A500 071610  70500-3A 3A500 091310  70500-A A500 060810  70500-A A500 072610  70500-A A500 092810  70550-A A550 072610  70602-3A 3A602 072310  70602-3A 3A602 080510  70604-6A 6A604 082310  70630-3A 3A630 072910 70640-4A 4A640 071609  70808-6A 6A808 081310  70808-6A 6A808 082610  70910-A A910 082310  70910-A A910 082610
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA,K CT, FL, GA, IL, IA, LA, MD, MA, MN, MS, MO,K MT, NE, NJ, NY, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY.
  • Product Description
    Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue Earth, MN 56013. || Following Cup and Dip product models involved in the recall: || 40900 || 40901 || 30500-A || 30575 -A || 30603-A || 30671-A || 30800-A || 30802-3A || 30900-A || 30950-A || 31102-A || 40901C || 60410-3A || 60500-A || 60505-A || 60524-A || 60526-A || 60535-A || 60600-A || 60602-4A || 60630-A || 60635-4A || 60640-4A || 60705-4A || 60709-A || 60800-6A || 60800-A || 60801-A || 60820-A || 60903-A || 60910-A || 60921-A || 60925-A || 60930-A || 61020-A || 61023-A || 61026-4A || 61028-3A || 61030-3A || 61044-6A || 61052-4A || 61100-A || 61204-A || 61206-4A || 61206-6A || 61303-A || 61401-A || 61404-A || 65500-4A || 70410-4A || 70500-3A || 70500-A || 70550-A || 70602-3A || 70604-6A || 70630-3A || 70640-4A || 70808-6A || 70910-A || In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine.
  • Manufacturer
    Express Diagnostics Int'l., Inc.

Manufacturer

Express Diagnostics Int'l., Inc.
  • Manufacturer Address
    Express Diagnostics Int'l., Inc., 1550 Industrial Dr, Blue Earth MN 56013-1100
  • Manufacturer Parent Company (2017)
    Express Diagnostics Intl Inc.
  • Source
    USFDA