Events

Rappel de Device Recall DrugCheck

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Express Diagnostics Int'l., Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    58652
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2387-2011
  • Date de mise en oeuvre de l'événement
    2011-03-18
  • Date de publication de l'événement
    2011-05-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99781
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Enzyme immunoassay, opiates - Product Code DJG
  • Cause
    Express diagnostics int'l, inc. has initiated a medical device recall on various model numbers of drugcheck devices, this recall was due to incorrect product expiration dating after findings from an fda inspection. use of expired product may not work properly, and may give incorrect screening results.
  • Action
    The firm, Express Diagnostic Int'l, Inc., sent an "Urgent Recall of DrugCheck Product" letter dated April 19, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine the product; notify Express Diagnostic of the quantity even if no product is remaining; complete and return the DISTRIBUTOR/CUSTOMER RECALL CONFIRMATION FROM via fax to 1-507-526-2252 as soon as possible. In addition, if they have further distributed the product to identify their customers and notify them of the recall. Provided procedures to be followed for them to destroy the quarantined product. Express Diagnostics will replace the DrugCheck Drug Screen devices. If you have any questions, please contact the Quality Assurance Manager at 507-526-3951, ext. 117.

Device

Device Recall DrugCheck
  • Modèle / numéro de série
    Product Code Lot Number   70801-4 4-801 112210 70801-4 4-801 102910 65500-4A 4A-500 110310  30705 705 112210 60702-6A AUS 6A-702 112910 60702-6A AUS 6A-702 113010 60600-A A600 110310 61205 205 110410 70701-4 4-701 102910 31012-6 6-012 110310 31003 003 102510
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: FL, IA, MD, OK, and WA; and countries including: AUSTRALIA and ITALY.
  • Description du dispositif
    DrugCheck, Manufactured by: Express Diagnostics Int;l Inc. 1550 Industrial Drive, Blue Earth MN 56013 USA, Model numbers : || 70801-4(NxScan OnSite, AMP500-COC-MDMA-MET500-MTD-OP1300-TCH-BUP-pH,SG-NI,CR, Lot 4-801 102910, Exp APR 2012, & Lot 4-801 112210, Exp MAY 2012, Export Only); || 65500-4A (AMP-COC--OP1-TCH-MET-ALC-pH,SG-NI,CR, Lot 4A-500 110310, Exp MAY 2012, For forensic use only); || 30705 ( DIP DRUG TEST, AMP500/COC/MDMA/MET500/MTD/OP1300/TCH, Lot 705 112210, Exp MAY 2012); || 60702-6A AUS (AMP300-COC300-OP1300-OP12000-MET300-TCH50-BZ0200-ALC-pH,SG,OX-NI,CR-GL, Lot 6A-702 113010 & 6A-702 112910, Exp MAY 2012, Export Only); || 60600-A (AMP-COC--OP1-TCH-MET-BZO-ALC, Lot A600 110310, Exp MAY 2012, For forensic use only); || 61205 (AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-TCA-THC, Lot 205 110410, Exp MAY 2012); || 70701-4 (NxScan OnSite, AMP500-COC-MDMA-MET500-MTD-OP1300-TCH-pH,SG-NI,CR, Lot 4-701 102910, Exp APR 2012, Export Only); || 31012-6 (DIP DRUG TEST, AMP/BAR/BZO/COC/MDMA/MTD/OPI/OXY/ PCP/THC/pH SG, OX/NI, CR, GL, Lot 6-012 110310, Exp MAY 2012); || 31003 (AMP/COC/OP10300/THC/MET/BZO/BAR/PCP/MTD/TCA/MET, Lot 003 102510, Exp APR 2012); || Intended use: The DrugCheck Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
  • Manufacturer
    Express Diagnostics Int'l., Inc.

Manufacturer

Express Diagnostics Int'l., Inc.
  • Adresse du fabricant
    Express Diagnostics Int'l., Inc., 1550 Industrial Dr, Blue Earth MN 56013-1100
  • Société-mère du fabricant (2017)
    Express Diagnostics Intl Inc.
  • Source
    USFDA