Events

Recall of cCrea A+B Membranes used with ABL800 series blood gas analyser rangeItem # 942-073, 08088 Crea A + 08089 Crea B membran

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Radiometer Pacific Pty Ltd.

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
    RC-2015-RN-00537-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00537-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    In november 2014, radiometer pacific notified customers (tga ref: rc-2014-rn-01201-i) that the ccrea results for qc decrease to below the lower acceptance limit within the lifetime of the crea membranes. the corrective action implemented at that time was to perform one quality control measurement every 24 hours using s7835 autocheck 6+, level 1 (944-094) to verify the ccrea performance. if the qc result was out of range, new crea a and crea b membranes had to be installed.Radiometer has now resolved the problem (starting with lot 557 and onwards) with narrowed specifications for the membrane material to reduce the diffusion rate through the membrane and has verified that the change brings the performance (drift and lifetime) back to the previous level.
  • Action
    For membrane units below Lot 557: Continue to perform one quality control measurement every 24 hours using S7835 AutoCheck 6+, level 1 to verify the cCrea performance. If the QC result is out of range, new Crea A and Crea B membranes must be installed. Alternatively, if you wish to return any remaining unused units of cCrea membrane from Lots below 557 please contact your local Radiometer Account Manager on 1800 247 254. For membrane units of Lot 557 onwards: You may return to your standard practice for running QC for the cCrea membranes. This action has been closed-out on 17/08/2016.

Device

cCrea A+B Membranes used with ABL800 series blood gas analyser rangeItem # 942-073, 08088 Crea A ...
  • Model / Serial
    cCrea A+B Membranes used with ABL800 series blood gas analyser rangeItem # 942-073, 08088 Crea A + 08089 Crea B membranLot Numbers: 557 onwardsARTG Number: 229300
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd