Radiometer America Inc Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Brand
Radiometer America Inc
Lot Codes / Batch Numbers
Lot R0040, expiration date February 2008, Lot R0042, expiration date April 2008.
Products Sold
Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.
Radiometer America Inc is recalling Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for qual due to The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45.
Recommended Action
Per FDA guidance
Radiometer sent Field Action Notes regarding the affected product. The note identified the product, the problem and the action to be taken by the customer. Instead of scanning the barcorde on the insert to enter the QC data into the anyalyzer, customers were instructed to manually key in the QUALICHECK type, lot number, and correct control range. For questions regarding this recall call 440-871-8900.
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
KY, NY, NC
Page updated: Jan 10, 2026