Radiometer America Inc Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004.
Brand
Radiometer America Inc
Lot Codes / Batch Numbers
All analyzers manufactured from 8/1998-11/2004, and the Nxxx number denotes the individual instrument within the run.
Products Sold
All analyzers manufactured from 8/1998-11/2004, are subject to recall. 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-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 t due to Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and Sodium (Na).
Recommended Action
Per FDA guidance
The consignees were notified of this recall by a letter, dated 9/29/2005. The letter informs the customers of this potential problem and the availability of new updated software which will correct the problem. The letter goes on to inform the customer that a Radiometer Service Engineer wil be contacting them shortly in order to arrange for a convenient time to install the software update. Along with the letter, the customer is provided a copy of an additional page and a CD concerning the function and operation of the new software, which is to be added to the customer''s Operator''s Manual.
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