Events

Recall of Device Recall StatSampler

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by StatSpin, Inc., dba Iris Sample Processing.

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
    48685
  • Event Risk Class
    Class 2
  • Event Number
    Z-2234-2008
  • Event Initiated Date
    2008-06-20
  • Event Date Posted
    2008-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71864
  • 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
    Blood Collection Tubes - Product Code JKA
  • Reason
    Edta inadvertently mixed with lithium heparin solution contained in capillary tubes.
  • Action
    Iris Sample Processing notified customers by telephone followed by an Urgent: Product Recall letter dated 6/19/08. Users are requested to return inventory, to not use product from Lot Number 7296, and to repeat tests where the recalled tubes were used. The firm identified an additional lot : 8031 was effected and recalled the lot to two consignees.

Device

Device Recall StatSampler
  • Model / Serial
    Lot number: 7296 Expiration Date: 12/09; Lot 8031 Expiration Date: 3/10
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of CA, CO, FL, KY, KS, GA, NC, NJ, OR, PA, and countries of Canada, Hong Kong, UK.
  • Product Description
    StatSampler 200 uL, Li Heparin (micro blood collector) || Ref: SS2H || Packed in Catalog Numbers: || SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit) || Intended for collection and processing of capillary blood to prepare plasma/serum.
  • Manufacturer
    StatSpin, Inc., dba Iris Sample Processing

Manufacturer

StatSpin, Inc., dba Iris Sample Processing
  • Manufacturer Address
    StatSpin, Inc., dba Iris Sample Processing, 60 Glacier Dr, Westwood MA 02090-1800
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA