Events

Recall of Device Recall Piccolo Comprehensive Metabolic Panel

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

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
    57321
  • Event Risk Class
    Class 2
  • Event Number
    Z-1066-2011
  • Event Initiated Date
    2010-11-19
  • Event Date Posted
    2011-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95843
  • 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
    Nadh oxidation/nad reduction, alt/sgpt - Product Code CKA
  • Reason
    Abaxis has determined that during the manufacture of product lot 0396bc5 may report inaccurate values of alanine aminotransferase (alt) when used in the piccolo blood chemistry analyzer or piccolo xpress chemistry analyzer.
  • Action
    The firm, Abaxis Inc., sent an "URGENT PRODUCT RECALL NOTICE" dated November 19, 2010, to all customers. The notice described the product, problem and action to be taken by the customers. The customers were instructed to check their inventory of the lot for boxes #0665 or higher; if found, to discontinue use; contact Abaxis for immediate replacement; complete and return the enclosed PRODUCT RECALL RESPONSE form to Abaxis Technical Support via fax at 1-877-349-2087, and ensure that their laboratory staff is informed of this recall notice. If you have any questions regarding this Product Recall Notice, please contact Abaxis Medical Technical Support at 800-822-2947, or at medtechsupport@abaxis.com.

Device

Device Recall Piccolo Comprehensive Metabolic Panel
  • Model / Serial
    Lot Number: 0396BC5  Boxes # 686 - 834 and # 665-685.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries of: Kowloon and Germany.
  • Product Description
    Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028; || Product is manufactured and distributed by Abaxis, Incorporated, || Union City, CA || The Piccolo Comprehensive Metabolic Reagent Disc, used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma or serum. The patented self¿contained reagent rotors are bar coded, contain liquid diluents and dry reagents and use centrifugal and capillary technology to provide the most commonly requested chemistry panel results in approximately 12 minutes. The Piccolo Comprehensive Metabolic Panel, used with the Piccolo Blood Chemistry Analyzer is a diagnostic system that aids in disease diagnosis or monitoring disease treatment.
  • Manufacturer
    Abaxis, Incorporated

Manufacturer

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