medical Class II Updated 2019-03-13

Abbott Laboratories, Inc recalls ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Mag

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: (a) 7D70 21 Lot Number UDI Number 36338UN17 (01)00380740012922(17)190106(10)36338UN17 79865UN17 (01)00380740012922(17)190309(10)79865UN17 12921UN17 (01)00380740012922(17)190503(10)12921UN17 43618UN17 (01)00380740012922(17)190609(10)43618UN17 45337UN17 (01)00380740012922(17)190714(10)45337UN17 84994UN17 (01)00380740012922(17)191012(10)84994UN17 24856UN17 (01)00380740012922(17)191113(10)24856UN17 41652UN18 (01)00380740012922(17)200120(10)41652UN18 99639UN18 (01)00380740012922(17)200226(10)99639UN18 99661UN18 (01)00380740012922(17)200413(10)99661UN18 78493UN18 (01)00380740012922(17)200725(10)78493UN18 95220UN18 (01)00380740012922(17)200907(10)95220UN18 31428UN18 (01)00380740012922(17)201031(10)31428UN18 33784UN18 (01)00380740012922(17)200611(10)33784UN18 (b) 7D70-31 36339UN17 (01)00380740012939(17)190106(10)36339UN17 97389UN17 (01)00380740012939(17)190309(10)97389UN17 12922UN17 (01)00380740012939(17)190503(10)12922UN17 43616UN17 (01)00380740012939(17)190609(10)43616UN17 45338UN17 (01)00380740012939(17)190714(10)45338UN17 84993UN17 (01)00380740012939(17)190901(10)84993UN17 08788UN17 (01)00380740012939(17)191012(10)08788UN17 24857UN17 (01)00380740012939(17)191113(10)24857UN17 41651UN18 (01)00380740012939(17)200129(10)41651UN18 99640UN18 (01)00380740012939(17)200226(10)99640UN18 99662UN18 (01)00380740012939(17)200413(10)99662UN18 33783UN18 (01)00380740012939(17)200509(10)33783UN18 33785UN18 (01)00380740012939(17)200611(10)33785UN18 78859UN18 (01)00380740012939(17)200725(10)78859UN18 95341UN18 (01)00380740012939(17)200907(10)95341UN18 31429UN18 (01)00380740012939(17)201031(10)31429UN18
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