Abbott Laboratories, Inc recalls ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in huma…

Recall date

January 2, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0971-2019

FDA classification

Class II

Brand / firm

Abbott Laboratories, Inc

Sold / distributed

Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.