Events

Retiro De Equipo (Recall) de Device Recall Lyophilized Chemistry Calibrator Level 1 and Level 2

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 Beckman Coulter 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
    78699
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0605-2018
  • Fecha de inicio del evento
    2017-08-24
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160143
  • 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
    Calibrator, multi-analyte mixture - Product Code JIX
  • Causa
    Unpaired lots of au lyophilized chemistry calibrator level 1 and 2 have been distributed. calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination. if lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results. qc failures could occur if incorrect pairs of calibrators are used.
  • Acción
    On August 28, 2017 a letter was sent to all the customers stating the following: Attention Beckman Coulter Customer, Beckman Coulter is initiating a field action for the product listed above. This letter contains important information that needs your immediate attention. ISSUE: ¿ Unpaired lots of AU Lyophilized Chemistry Calibrator level 1 and 2 have been distributed. ¿ Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination. ¿ Paired calibrator lots are identified by the last two digits of the lot number. Calibrator Level 1  REF DR0070-1, Lot 6101K51 Calibrator Level 2  REF DR0070-2, Lot 6102K61 Incorrect pair Calibrator Level 1  REF DR0070-1, Lot 6101K61 Calibrator Level 2  REF DR0070-2, Lot 6102K61 Correct pair IMPACT: ¿ If lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results. ¿ QC failures could occur if incorrect pairs of calibrators are used. Calibrator Level 1  REF DR0070-1, Lot 6101K51 Calibrator Level 2  REF DR0070-2, Lot 6102K61 Incorrect pair ¿ If the above incorrect pair is run with Level 1 lot 6101K51and Level 2 lot 6102K51 set points, erroneous results could be generated for the following assays: o Bicarbonate : maximum 11% bias low o Calcium Arsenazo : maximum 5% bias low o Calcium oCPC : maximum 5% bias low o Inorganic Phosphorous : 6.4% bias high o Magnesium: 3.2% bias low ¿ If the above incorrect pair is run with Level 1 lot 6101K61 and Level 2 lot 6102K61 set points, erroneous results could be generated for the following assays: o Bicarbonate : maximum 15.8% bias high o Direct Bilirubin OSR6x181: 8.7% bias low ACTION: ¿ Check the level 1 and level 2 calibrators to make sure you are using correctly paired lots for calibration. ¿ Ensure correct set points are being used for the lot. Set points are in the IFU for each lot and can be found in each kit, or on the Beckman Coulter websites

Device

Device Recall Lyophilized Chemistry Calibrator Level 1 and Level 2
  • Modelo / Serial
    Lots # 6101K51 and 6101K61
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution in the states of AL, AK, AZ, AK, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IO, KS, KY, LA, MA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NY, NM, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VI, WA, WV, WI, and WY and the countries of Brazil, Canada, Costa Rica, El Salvador, Guam, Paraguay, and Peru
  • Descripción del producto
    Lyophilized Chemistry Calibrator Level 1 || Product Usage: || Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based products formulated for use as a reference material when calibrating Beckman Coulter AU clinical chemistry system assays. The calibrators are used to calibrate the following assays: Albumin (ALB), Bicarbonate (CO2), Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Calcium Arsenazo (CALA), Calcium (CAL oCPC), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Phosphorus (PHOS), Iron, Lactate, Magnesium (MG), Total Protein (TP), Triglyceride (TRIG), Unbound Iron Binding Capacity (UIBC), Urea Nitrogen (BUN), and Uric Acid. Only lots 6101K51 and 6101K61 were subject to recall.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA