Radiometer America Inc ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device).
Brand
Radiometer America Inc
Lot Codes / Batch Numbers
ABL700 Series (902-441)
Products Sold
ABL700 Series (902-441)
Radiometer America Inc is recalling ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device). due to Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 3. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to perform measurements and obtain questionable results.
Recommended Action
Per FDA guidance
On February 28, 2008, a Field Action Notes Letter was issued advising them about a Mandatory Software Update. Customers were notified of the problem by fax and letter (Fed Ex). The Recall Letter instructed the user to disable the parameter bar feature and only rely on the traffic light system indicator which properly indicates system errors. The letter includes instructions to temporarily fix the problem and notice of a update of the software module that updates the parameter bar. If you have any questions contact Vincent Sigmund at (440)-871-8900 ext. 209.
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 noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026