Events

Recall of Synchron Systems(s) Creatinine Reagent (CREm)

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
    56424
  • Event Risk Class
    Class 2
  • Event Number
    Z-2389-2010
  • Event Initiated Date
    2010-08-02
  • Event Date Posted
    2010-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93640
  • 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
    Alkaline picrate, colorimetry, creatinine - Product Code CGX
  • Reason
    The recall was initiated after beckman coulter confirmed reports that black / brown particulates were observed in some bottles of the creatinine alkaline buffer (buffer lot m911427 and m911518) in modular creatinine (crem) reagent kit lots m911428 and m911519. beckman coulter have had reports of erroneous results when using the lots of creatinine alkaline buffer listed above. single creatinine d.
  • Action
    The firm, Beckman Coulter, sent a "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 3, 2010, to all customers. The letter describes the product, problem, and action to be taken by customer. The customers were instructed to: (1) Please discontinue use of Creatinine (CREm) reagent kit lots M911428 and M911519 and discard appropriately. (2) Please contact Beckman Coulter at (800) 526-3821 in the United States or (800) 463-7828 in Canada to discuss CREm kit M911428 and M911519 replacement options. Outside the United States and Canada, please contact your local Beckman Coulter Representative. (3) Please complete and return the enclosed response form within 10 days so that we may maintain our records. (4) Please share this information with their laboratory staff and retain this notification as part of their Quality System documentation. If you have forwarded the affected products listed above to another laboratory, please provide a copy of this letter to them. If customers have any questions regarding this Product Corrective Action letter, they were instructed to please contact Beckman Coulter's Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/Support Requests, or call (800) 854-3633 in the United States and Canada.

Device

Synchron Systems(s) Creatinine Reagent (CREm)
  • Model / Serial
    Lot Number(s): M911428 & M911519
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, KS, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY and country of Canada
  • Product Description
    SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 || Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine. || CREm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 800 System and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA