Events

Retiro De Equipo (Recall) de Device Recall VersaTREK Automated Microbial Detection System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Remel Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    71291
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1841-2015
  • Fecha de inicio del evento
    2015-05-19
  • Fecha de publicación del evento
    2015-06-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137244
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, blood culturing - Product Code MDB
  • Causa
    Use of the recalled product may result in false positive reports.
  • Acción
    Remel, Inc. a part of Thermo Scientific sent a Product Correction Notification dated May 19, 2015, to all affected customers. The notification states the problem with the device and that the recalling firm's Technical Services department will be contacting the customer to schedule a field service of the device to correct the issue. Customers were instructed to notify any personnel who need to be notified of the potential for a false positive resulting from rare inconsistent barometric pressure readings. Return the attached Medical Device Recall Return Response form acknowledging receipt of the notice of the affected product. If product was further distributed customers were instructed to contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact the Technical Services Department at 800-642-7029. For questions regarding this recall call 770-409-0713.

Device

Device Recall VersaTREK Automated Microbial Detection System
  • Modelo / Serial
    Serial numbers: 0169039201140624, 0169040501140626, 0169050101141007, 0169068601141216, 0169078101150213, 2163X1013, 2164X1013, 2165X1013, 2166X1013, 2167X1013, 2168X1013, 2169X1013, 2170X1013, 2171X1013, 2172X1013, 2173X1013, 2174X1013, 2175X1013, 2176X1013, 2177X1013, 2178X1013, 2179X1013, 2180X1013, 2181X1013, 2182X1013, 2183X1013, 2184X1013, 2185X1013, 2186X1013, 2187X1013, 2188X1013, 2189X1013, 2190X1013, 2191X1013, 2192X1113, 2193X1113, 2194X1113, 2195X1113, 2196X1113, 2199X1113, 2201X1113, 2202X1113, 2203X1113, 2204X1113, 2205X1113, 2206X1113, 2207X1113, 2208X1113, 2209X1113, 2210X1113, 2211X1113, 2212X1113, 2213X1113, 2214X1113, 2216X1113, 2217X1113, 2218X1213, 2219X1213, 2220X1213, 2221X1213, 2222X1213, 2223X1213, 2224X1213, 2225X1213, 2226X1213, 2227X1213, 2228X1213, 2229X1213, 2230X1213, 2231X1213, 2232X1213, 2233X1213, 2234X1213, 2235X1213, 2237X1213, 2238X1213, 2239X1213, 2240X1213, 2241X1213, 2242X1213, 2243X1213, 2245X1213, 2249X0114, 2250X0114, 2251X0114, 2252X0114, 2253X0114, 2254X0114, 2255X0114, 2256X0114, 2257X0114, 2261X0114, 2262X0114, 2263X0114, 2264X0114, 2268X0114, 2269X0114, 2276X0214, 2277X0214, 2278X0214, 2279X0214, 2280X0214, 2281X0214, 2282X0214, 2286X0214, 2287X0214, 2288X0214, 2289X0214, 2290X0214, 2306X0714, 2307X0714, 2309X0714, 2311X0714, 2312X0714, 2314X0714, 2315X0714, 2316X0714, 2317X0714, 2318X0714, 2320X0714, 2321X0814, 2322X0814, 2323X0814, 2330X0814, 2332X0814, 2333X0814, 2334X0814, 2336X0814, 2337X0814, 2338X0814, 2339X0814, 2340X0814, 2342X0814, 2345X0914, 2346X0914, 2347X0914, 2348X0914, 2349X0914, 2352X0914, 2353X0914, 2359X0914, 2365X0914, and 2366X0914;
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.
  • Descripción del producto
    VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. || The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
  • Manufacturer
    Remel Inc

Manufacturer

Remel Inc
  • Dirección del fabricante
    Remel Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Empresa matriz del fabricante (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA