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.
Check against the official notice below — it lists the full affected range.
Abbott Laboratories has recalled its ARCHITECT MAGNESIUM assay (models 7D70-21 and 7D70-31), which is used to measure magnesium levels in human serum, plasma, or urine. Abbott internal testing found that the magnesium urine application produces depressed results, with all urine samples above 0.5mEq/L failing linearity acceptance criteria and showing depressed recovery of up to 37%. The cause of this negative bias is still under investigation. A total of 24,995 units were distributed worldwide, including throughout the United States and to China, Thailand, Guatemala, and El Salvador.
The recall affects multiple lot numbers for both the 7D70-21 and 7D70-31 models, with specific UDI numbers and lot identifiers listed in the recall documentation. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR. Quantity: 24,995 units 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)78859UN1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.