FDA-Device2019-03-13Class II
ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.
Abbott Laboratories, Inc
Hazard
Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias specification and demonstrate depressed recovery of up to 37%. The specific cause of the negative bias/depressed results is currently under investigation.
Sold states
Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR.
Affected count
24,995 units
Manufactured in
1921 Hurd Dr, N/A, Irving, TX, United States
Products
ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0971-2019Don't want to check this manually?
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