Events

Recall of 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
    59632
  • Event Risk Class
    Class 2
  • Event Number
    Z-3113-2011
  • Event Initiated Date
    2010-10-04
  • 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=103203
  • 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
    Enzyme immunoassay, propoxyphene - Product Code JXN
  • Reason
    Express diagnostics int'l, inc (edi), is recalling drugcheck¿ drug screen cups containing buprenorphine (bup) and propoxyphene (ppx) because they must be labeled as "forensic use only", meaning they cannot be distributed or used for treatment or diagnostic purposed in the united states.
  • Action
    The firm, Express Diagnostics Int'l, Inc., sent a "RECALL NOTICE" letter dated October 4, 2010 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to notify their customers of the labeling change, and complete and return the DISTRIBUTOR/CUSTOMER CONFIRMATION FORM via fax to Express Diagnostics Int'l, Inc., at 1-507-526-2252. The letter also noted that "Further shipment of product containing BUP and/or PPX cannot continue until Express Diagnostics Int'l, Inc. receives the signed form." If you have any questions, call 507-526-3951.

Device

DrugCheck
  • Model / Serial
    Product Lot # 60670 670052010 60670 670070209 60670 670101409 60670 670110409 60670 670121609 60700 700031910 60700 700040709 60700 700042810 60700 700060310 60700 700062209 60700 700062510 60700 700071509 60700 700072209 60700 700072310 60700 700081309 60700 700090110 60700 700090409 60700 700110409 60700 700121009 60700 700122909 60713 713030310 60713 713072109 60717 717040110 60717 717051510 60717 717051810 60717 717070610 60717 717082310 60870 870020110 60870 870042810 60923 923012010 60923 923042010 60923 923050509 60923 923060109 60923 923062210 60923 923062909 60923 923080409 60923 923082310 60923 923100709 60923 923111009 60923 923120209 61012 12071910 61019 19072110 61019 19121609 61023 23020910 61023 23052810 61023 23060909 61023 23061610 61023 23062309 61023 23082009 61023 23082509 61023 23110409 61024 24021910 61024 24050609 61024 24051310 61024 24062210 61024 24070709 61024 24071709 61024 24072910 61024 24082609 61024 24090909 61024 24102309 61024 24122909 61024 24151310 61024 27071709 61040 40110308 61042 42080910 61057 57080610 61102 102052410 61102 102052909 61102 102061610 61102 102061709 61102 102081009 61102 102090909 61102 102092509 61102 102103009 61102 102121409 61105 105032310 61203 203101209 61204 204021910 61204 204051310 61204 204062210 61204 204070709 61204 204102309 61204 204122909 61206 206012110 61206 206050510 61206 206050510 61208 208072310 61208 208090109 61208 208090110 61208 208111209 61208 208112309 61301 301010710 61301 301011910 61301 301101409 61303 303121009 61401 401010510 61401 401011910 61401 401030310 61401 401040710 61401 401042810 61401 401052010 61401 401070710 61401 401072810 61401 401091409 61401 401100709 61401 401121709 70603 603080310 70809 809091010 71032 32022310 71032 32050710 71032 32051209 71032 32052209 71032 32060810 71032 32071410 71032 32081809 71032 32091709 71032 32103009 71032 32112309 71043 43061010 71043 43062209 71043 43070609 71043 43071210 71043 43072209 71043 43081709 71043 43082410 71043 43090209 71055 55011110 71055 55012610 71055 55022310 71055 55031609 71055 55031710 71055 55052709 71055 55060110 71055 55061610 71055 55070209 71055 55070509 71055 55070710 71055 55082609 71055 55091709 71055 55102009 71055 55111909 71055 55112309 71055 55031710 71065 65012610 71065 65040809 71065 65042010 71065 65072809 71065 65082609 71065 65091710 71065 65100109 71202 202011510 71202 202081709 71202 202111909 71204 204010510 71204 204030510 71204 204041210 71204 204041910 71204 204050510 71204 204051409 71204 204060310 71204 204061509 71204 204062509 71204 204070710 71204 204072810 71204 204080409 71204 204081009 71204 204081309 71204 204082510 71204 204090309 71204 204090909 71204 204091310 71204 204092109 71204 204100609 71204 204102309 71204 204111809 71204 204111909 71204 204120809 71204 204121409 71204 204123109 71205 205010710 71205 205031910 71205 205070910 71205 205072510 71205 205072810 71205 205100909 71205 205110309 71401 401031610 71402 402041210 60718-3 3718040110 60718-3 3718091010 60720-6 6720082310 60925-A A925081209 60927-3 3927011410 60927-3 3927060209 60930-A A930081110 60980-3A 3A980070109 61002-3 3102052609 61010-4 401052010 61010-4 401063010 61010-4 401080210 61010-4 401083109 61010-4 401110209 61010-4 401111109 61010-4 401113009 61023-A A023051110 61023-A A023010710 61023-A A023041210 61023-A A023081109 61028-3A 3A028010510 61028-3A 3A028032210 61028-3A 3A028060109 61028-3A 3A028092909 61039-4 4039020110 61039-4 4039032310 61039-4 4039042009 61039-4 4039050110 61039-4 4039051110 61039-4 4039061510 61039-4 4039073109 61039-4 4039102009 61040-A A040080210 61055-A A055040110 61056-3 3056061410 61057-6 6057062510 61100-3 3100082509 61102-3 3102012610 61102-3 3102021110 61102-3 3102032310 61102-3 3102040710 61102-3 3102041410 61102-3 3102041509 61102-3 3102051310 61102-3 3102052609 61102-3 3102062510 61102-3 3102062909 61102-3 3102070610 61102-3 3102071910 61102-3 3102082009 61102-3 3102082509 61102-3 3102090209 61102-3 3102093009 61102-3 3102102009 61102-3 3102121409 61104-3 3104012010 61104-3 3104021110 61104-3 3104031610 61104-3 3104041510 61104-3 3104042810 61104-3 3104072110 61104-3 3104072210 61104-3 3104081710 61104-3 3104091010 61104-3 3104102209 61104-3 3104102909 61104-3 3104110209 61104-3 3104121609 61105-5 CRL CRL5105062210 61105-5 CRL CRL5105081110 61105-5 CRL CRL5105082710 61120-3 3102102009 61202-4 4202012010 61202-4 4202012909 61202-4 4202032509 61202-4 4202041509 61202-4 4202060410 61202-4 4202061909 61202-4 4202090809 61202-4 4202092909 61202-4 4202122909 61204-4 4202012010 61204-4 4204041509 61204-4 4204061909 61204-A A204030810 61204-A A204050310 61204-A A204061010 61204-A A204062609 61204-A A204072909 61204-A A204100609 61204-A A204121409 61204-A A207072909 61206-3A 3A206032310 61207-4 4207012610 61207-4 4207042810 61207-4 4207062310 61207-4 4207071610 61207-4 4207072409 61207-4 4207111309 61302-3 3203032910 61302-3 3302020310 61302-3 3302021510 61302-3 3302021809 61302-3 3302060810 61303-A A303031909 61401-A A401031510 70660-3 3660081009 70716-3 3716060109 71045-A A045081909 71055-6 6055052610 71102-3A 3A102082709 71204-4 4204010710 71204-4 4204081310 71206-3A 3A102082709 71206-3A 3A206012110 71206-3A 3A206070109 71206-3A 3A206071009 71206-3A 3A206081109 71206-3A 3A206090809 71206-3A 3A206091709 71206-3A 3A206121409 72106-3A 3A206081109
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution:AZ, CA, CT, GA, MD, MA, MN, MO, NH, NJ, OR, SC, and WA.
  • Product Description
    DrugCheck¿, Distributed by Express Diagnostics Int'l Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following cup Model numbers involved in the recall: 60670, 60700, 60713, 60717, 60870, 60923, 61012, 61019, 61023, 61024, 61040, 61042, 61057, 61102, 61105, 61203, 61204, 61206, 61208, 61301, 61303, 61401, 70603, 70809, 71032, 71043, 71055, 71065, 71202, 71204, 71205, 71401, 71402, 60718-3, 60720-6, 60925-A, 60927-3, 60930-A, 60980-3A, 61002-3, 61010-4, 61023-A, 61028-3A, 61039-4, 61040-A, 61055-A, 61056-3, 61057-6, 61100-3, 61102-3,61104-3,61105-5 CRL,61120-3,61202-4,61204-4,61204-A,61206-3A,61207-4,61302-3, 61303-A, 61401-A, 70660-3, 70716-3, 71045-A, 71055-6, 71102-3A, 71204-4, 71206-3A. || 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