Events

Recall of Device Recall Lyophilized Chemistry Calibrator Level 1 and Level 2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78699
  • Event Risk Class
    Class 2
  • Event Number
    Z-0605-2018
  • Event Initiated Date
    2017-08-24
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160143
  • Notes / Alerts
    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.
  • Extra notes in the data
    Calibrator, multi-analyte mixture - Product Code JIX
  • Reason
    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
  • Model / Serial
    Lots # 6101K51 and 6101K61
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    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.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA