Events

Rappel de Device Recall Lyophilized Chemistry Calibrator Level 1 and Level 2

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 Beckman Coulter 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
    78699
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0605-2018
  • Date de mise en oeuvre de l'événement
    2017-08-24
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160143
  • 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
    Calibrator, multi-analyte mixture - Product Code JIX
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Lots # 6101K51 and 6101K61
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    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.
  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA