Events

Recall of Device Recall DSL108000 Active IPTH ELISA

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
    55195
  • Event Risk Class
    Class 2
  • Event Number
    Z-0107-2011
  • Event Initiated Date
    2010-03-04
  • Event Date Posted
    2010-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90278
  • 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
    Radioimmunoassay, parathyroid hormone - Product Code CEW
  • Reason
    The recall was initiated after beckman coulter confirmed that the stated stability of the dsl-10-8000 i-pth elisa assay may not be achieved for lot numbers: 891198, 990980 and 991448. the kit lot numbers listed above passed the stability testing performed at 6 months, but failed the testing performed at 12 months. therefore the affected i-pth elisa kit lots may produce falsely elevated patient r.
  • Action
    Beckman Coulter sent an URGENT: PRODUCT CORRECTIVE ACTION letter dated March 17, 2010 with attached Customer Response form to all customers who received Active I-PTH ELISA kits with the affected lot numbers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to: (1) Discontinue use of all materials provided with I-PTH ELISA kit lot numbers 891198, 990980 and 991448; (2) Review historical external quality control results to ensure the assay performance of these lots was within laboratory specifications. Retesting may be necessary if your laboratory uses only the control materials provided with the I-PTH ELISA kit; (3) Abnormally elevated patient results that are obtained with these lot numbers and that are inconsistent with the patient's clinical status should be reviewed in the context of other clinical diagnostic tests; (4) I-PTH ELISA kit lot numbers 891198, 990980 and 991448 will no longer be shipped. Alternate lots will be provided for current and future replenishment orders or requests. in addition customers were instructed to share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. Complete and return the enclosed response form within 10 days. For questions regarding this recall contact (800) 231-7970.

Device

Device Recall DSL108000 Active IPTH ELISA
  • Model / Serial
    Lot Numbers: 891198, 990980, 991448
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of CA, CT, IA, IL, MI, NY, SC, and TX
  • Product Description
    Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 || The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism
  • 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