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Radiometer America Inc recalls Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood
Recalled January 2, 2013 · FDA recall Z-0608-2013 · Radiometer America
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. · FDA Class III
Units
840 Ampules
Sold at
Distributed to KY, NC, and NY.
Description
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.
Product
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Manufacturer(s)
Radiometer America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →