Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series.
This recall has been terminated (originally issued August 2, 2006).
- Company
- Radiometer America Inc
- Recall Initiated
- June 17, 2005
- Posted
- August 2, 2006
- Terminated
- February 24, 2012
- Recall Number
- Z-1318-06
- Quantity
- 108 devices
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.
Distribution
Nationwide.
Lot / Code Info
All analyzers manufactured from 1/2005-10/31/2005. The devices contain serial numbers 902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx number denotes the individual instrument within the run.
Root Cause
Other
Action Taken
The customers were apprised of this situation with a recall letter issued by the firm on 6/17/2005. In addition, new Operators Manuals were sent to the customers. In the letter, the customers were advised that a Service Engineer would be contacting them shortly in order to arrange for the installation of the software upgrade. The firm''s Service Engineers visited each customer location and installed software upgrades. Version 3.831 software was installed on the 700 Series Analyzers and Version 4.14 was installed on the 800 Series Analyzers. According to the firm, these software corrections were verified as having been completed by 3/10/2006.