Events

Recall of Device Recall Osmetech OPTICCA, EGlu Cassettes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Osmetech 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
    29393
  • Event Risk Class
    Class 2
  • Event Number
    Z-1064-04
  • Event Initiated Date
    2004-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33661
  • 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
    Glucose Oxidase, Glucose - Product Code CGA
  • Reason
    In some cases patient samples with high glucose concentrations, above the reportable range of the opti-cca analyzer, may be erroneously reported as 'low'.
  • Action
    Consignees were notified by letter on 6/22/04. A separate Recall Notice was mailed to distributors outside the United States with instructions on issuing the recall notice to their affected customers in the appropriate language.

Device

Device Recall Osmetech OPTICCA, EGlu Cassettes
  • Model / Serial
    All OPTI-CCA Analyzers with software version 2.20 through 2.24 are affected. Catalog Number BP7564, Lot #351601, 401600, 401601, 405600, 405601, 406600, 406601, 405600, 405601, 410600, 412600, 415600, 415601, 417600, 419600, 419601, 419602 and 419603.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Argentina, Austria, Bolivia, France, Greece, Germany, Korea, India, Italy, Jordan, Netherlands, Sweden, Switzerland.
  • Product Description
    Osmetech OPTI-CCA Blood Gas Analyzer, Single Use, BP7564 OPTI¿E-Glu Cassettes.The cassettes are labeled, Roche OPTICCA Cassettes E-Glu. There are 25 cassettes in each box.
  • Manufacturer
    Osmetech Inc

Manufacturer

Osmetech Inc
  • Manufacturer Address
    Osmetech Inc, 235 Hembree Park Dr, Roswell GA 30076-5700
  • Source
    USFDA