Radiometer America Inc Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series.
Brand
Radiometer America Inc
Lot Codes / Batch Numbers
and the Nxxx number denotes the individual instrument within the run.
Products Sold
All analyzers manufactured from 1/1999-12/2005. The devices contain serial numbers 902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx number denotes the individual instrument within the run.
Radiometer America Inc is recalling Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series. due to 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 sa. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026