Events

Rappel de Device Recall Simplexa" HSV 1 & 2 Direct

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 Focus Diagnostics 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
    73283
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1272-2016
  • Date de mise en oeuvre de l'événement
    2016-02-10
  • Date de publication de l'événement
    2016-04-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144240
  • 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
    HSV-1 and HSV-2 CNS Nucleic-Acid Based Panel - Product Code PGH
  • Cause
    Focus diagnostics is recalling the direct amplification discs (dad) supplied with the simplexa hsv 1 & 2 direct (mol2150), simplexa flu a/b & rsv direct (mol2650) and simplexa group a strep direct kits (mol2850) because it may result in a false negative result, a false positive result or error code (s) 500 or 505, and it may result in higher invalid rates.
  • Action
    A customer notification letter dated 2/10/16 was sent to all their customers who received the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850). The letter informs the customers that Focus Diagnostics is recalling MOL2150 and MOL2650 kits because it may result in a false negative result, a false positive result or Error Code(s) 500 or 505. Additionally, some customers are reporting insufficient specimen volume errors which may result in higher invalid rates. In those cases, the error results in a Report Note Statement of Insufficient Specimen Volume. The letter informs the customers of the recommendations to be taken for the identified kits and the risks involved for positive results, negative results, and delayed results. The letter informs the customers of the actions to be taken. Customers are instructed to sign the achnowledgement form and email the form to Technicalinfo@focusdx.com or fax back to Focus Diagnostics Technical Services at (562) 240-6526 within 10 business days. On 2/11/16, Focus Diagnostics sent to their customers an amendment to the customer notification letter to clarify what is considered an "early Ct", Focus would consider Internal Control (IC) Ct's less than 25 as "early Ct". Customers are informed that if an internal control Ct is less than 25, additional testing may be necessary. On 2/15/16, Focus Diagnostics sent to their customers an amendment to the customer notification letter to inform them to determine if they had instances of early Cts less than 25, then to please refer to Section III  Analyzing Runs, pages 6-10 and 6-15 in the Focus Diagnostics, Operator Manual for Integrated Cycler Studio 6.0  For Use with IVD Assays in the USA. Also, for a more detailed analysis, customers are instructed to view excerpts from the ICS Operator Manual covering Section III, pages 6-10 and 6-16. On 3/17/16,

Device

Device Recall Simplexa" HSV 1 & 2 Direct
  • Modèle / numéro de série
    Item Number MOL1451, Lot/Serial: 151870, 152535,152359, 152550, 152551, 152756, 152770, 160008, 160009, 160198, 160201, 160248, 160262.  Item Number MOL1455, Lot/Serial: 29230, 29232, 29233, 29453, 29454, 29669, 29670, 29671, 29689, 29690, 29691, 29692, 29845, 29846, 29847, 29848, 29849, 29850, 30271, 30272, 30273, 30274, 30275, 30609, 30610, 30611, 30612, 30613, 30615, 30616, 30617, 30619, 30620.   3M Manufacturing Lot# (Pouch and White Box of 24 DAD): 2140887, 2140332, 2127423, 2159531, 2154010, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 2165236, 2183651, 2185129, 2216981, 2213066, 2210371, 2208204, 2205280, 2255456, 2255456, 2225778, 2230958, 2233449, 2265481 2258543.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: TX, CA, MA, NY, WA, MI, ME, IN, NJ, WV, OH, PA, HI, NH, CO, MN, FL, SC, IN, IA, TN, OR, AZ, WI, TN, IL. and the countries of: Australia, Brazil, Canada, Dominican Republic, Denmark, Ecuador, France, Germany, Israel, Kuwait, Spain, Sweden, Slovenia, Thailand, and United Kingdom.
  • Description du dispositif
    Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) || Model Number: MOL2150, MOL1451, MOL1452, MOL1455
  • Manufacturer
    Focus Diagnostics Inc

Manufacturer

Focus Diagnostics Inc
  • Adresse du fabricant
    Focus Diagnostics Inc, 11331 Valley View St, Cypress CA 90630-5366
  • Source
    USFDA