Events

Recall of Device Recall ABL 5 capillary adaptor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radiometer America 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
    35774
  • Event Risk Class
    Class 2
  • Event Number
    Z-1320-06
  • Event Initiated Date
    2005-06-09
  • Event Date Posted
    2006-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46847
  • 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
    in vitro diagnostic accessory - Product Code CHL
  • Reason
    The dimensions and shape of the analyzer adaptor do not fit the analyzer tubes or probe, causing air to be aspirated with the blood sample and causing a deviation in the po2 sample results.
  • Action
    The firm issued a letter to their customers dated 6/9/2005. The letter reports the defect with the ABL5 Capillary Adapters and informs the customers that Radiometer reps will be replacing all of the customers'' ABL5 adaptors ASAP. The letter is accompanied by a single bag of new adaptors for the customers'' ''immediate needs'' and also provides a faxed response form which the customer can use to request additional adapters as required. In addition, should the customer choose to use the old adapters in their possession, the letter stresses and reiterates the ''Precautions and Warnings'' applicable for use of the ABL5 should air bubbles be observed in the measuring chamber by the user/operator.

Device

Device Recall ABL 5 capillary adaptor
  • Model / Serial
    Part #906-018  lot 041643 to lot 045124
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including KS, OH, MD, FL, TX, CA, KY, MA, VA, WA, IL, AR and ME, and Canada.
  • Product Description
    ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Part Number: 906-018.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA