Events

Rappel de Device Recall Sysmex pocH100i

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 Sysmex America 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
    65722
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0100-2014
  • Date de mise en oeuvre de l'événement
    2013-05-15
  • Date de publication de l'événement
    2013-10-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119961
  • 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
    Counter, differential cell - Product Code GKZ
  • Cause
    The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
  • Action
    The firm, Sysmex, sent a "Product Notification-FIELD CORRECTION" letter dated May 2013 to all customers in the U.S. and Canada on May 15, 2013 by U.S. Mail. The letter describes the product, problem and actions to be taken. The customers will be contacted by a Sysmex Service Representative within the following 90 days to schedule an appointment to replace the Printed Circuit Board (PCB) on the internal printer. The repair will be performed during an on-site service visit. The customers were instructed to, until the repair can be made, use the thermal printer for reporting results; to compare the sample identification, values and decimal points on the printout with the data on the LCD screen for accuracy. If you have any questions concerning this information, please email the Sysmex Technical Assistance Center (TAC). Simply click on email TAC button on the home page of the CRC, complete the form that appears and then click the submit to send your question to TAC. Sending an email to TAC is recommended for non-urgent requests. For urgent request, call the Technical Assistance Center at 1-888-879-7639.

Device

Device Recall Sysmex pocH100i
  • Modèle / numéro de série
    Product Code: 023-1861-8;  Serial Numbers: B1677 - B1826, F1827 - F2161, F2178 - F2198, F2216 - F2396, F2411 - F2452, F2464 - F2472, F2495 - F2523, F2533, F2550 - F2560, F2592 - F2601, F2614 - F2635, F2640 - F2648, F2662 - F2679, F2710 - F2853, F2855 - F2871, F2878 - F2922, F2945, F2946, F2962 - F2970, F2998 - F3008, F3072 - F3080, F3083 - F3098
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and country of Canada.
  • Description du dispositif
    pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. || The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).
  • Manufacturer
    Sysmex America Inc

Manufacturer

Sysmex America Inc
  • Adresse du fabricant
    Sysmex America Inc, 577 Aptakisic Rd, Lincolnshire IL 60069-4325
  • Société-mère du fabricant (2017)
    Sysmex Corp.
  • Source
    USFDA