Events

Recall of Device Recall iChem 10 SG Urine Chemistry Strips

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
    72925
  • Event Risk Class
    Class 2
  • Event Number
    Z-0649-2016
  • Event Initiated Date
    2014-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142510
  • 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
    Method, enzymatic, glucose (urinary, non-quantitative) - Product Code JIL
  • Reason
    Iris international is recalling the ichem 10 sg urine chemistry strip because of false positive leukocyte result for samples that are truly negative.
  • Action
    An "Important Product Notice," dated 12/8/14 was sent to customers to inform them of the recall by Iris International. The recall letter informs customers that The identified lots of iChem 10 SG Urine Chemistry Strips may have leukocyte pads that are more sensitive at the first reporting range of 1+, corresponding to 25 white blood cells (WBCs) /microliter. The letter provides the impact of the recall and the actions to taken by the customers. Customers are instructed to discard any remaining strips from the affected lots and use another lot number. Customers can either contact their local Customer Service Support or complete and return the Replacement Order form, if replacement product is needed. The enclosed response form should be completed and returned within 10 days. Customers with questions are instructed to refer to http://www.beckmancoulter.com; (800) 854-3633 in US and Canada. Customers outside the US and Canada are instructed to contact their local support representative.

Device

Device Recall iChem 10 SG Urine Chemistry Strips
  • Model / Serial
    510033A, expiration 2015-03 510034A, expiration 2015-04 510035A, expiration 2015-07 510035B, expiration 2015-09
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Brazil, Canada, Chile, Ecuador, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Philippines, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Turkey, and United Arab Emirates.
  • Product Description
    iChem 10 SG Urine Chemistry Strips, PN 800-7005. || Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA