FDA-Device2013-01-02Class III
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Radiometer America Inc
Hazard
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.
Sold states
Distributed to KY, NC, and NY.
Affected count
840 Ampules
Manufactured in
810 Sharon Dr, N/A, Westlake, OH, United States
Products
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0608-2013Don't want to check this manually?
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