Recall of Device Recall PICCOLO(TM)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abaxis 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
    53848
  • Event Risk Class
    Class 2
  • Event Number
    Z-1155-2010
  • Event Initiated Date
    2009-11-16
  • Event Date Posted
    2010-03-16
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2010-12-14
  • Event Source
    USFDA
  • Event Source URL
  • 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
    analyzer, chemistry, centrifugal, for clinical use - Product Code JFY
  • Reason
    Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.
  • Action
    An "URGENT: PRODUCT RECALL NOTICE" dated November 16, 2009, was sent to customers. The notification described the product, issue/impact, and the action/resolution to be taken by the customers. The customers are to discontinue use of the specified lot, contact Abaxis for immediate replacement and complete and return the enclosed Response form within 5 working days. They may fax the form to Abaxis Technical Support at 1-510-315-3140. The customer are requested to ensure all laboratory staff are informed about this notice and retain this notification as a part of their laboratory Quality System documentation. The firm is currently contacting all direct shipment customers. If you have any questions regarding this Product Recall Notice, please contact Abaxis Medical Technical Support at 800-822-2947, extension 6505, or at medtechsupport@abaxis.com.

Device

  • Model / Serial
    Lot number 9284AC2, accidentally labeled as 9285AC2, catalog number 400-0028, expiration date 7/9/2010
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and Canada, EU and Asia
  • Product Description
    Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc., Union City, CA || Medical device for use in the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline Phosphatase (ALP), aspartate aminotransferase, calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen in heparinized whole blood, heparinized plasma or serum.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Abaxis Inc, 3240 Whipple Rd, Union City CA 94587
  • Manufacturer Parent Company (2017)
  • Source
    USFDA