FDAJanuary 2, 2019device

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

abbott laboratoriesabbott

UPCs

0038074001292200380740012939

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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