Abbott Recalls Architect Magnesium Assay Due to Depressed Urine Results
Abbott is recalling Architect Magnesium assays because urine tests may show falsely low results. The recall covers 24,995 units distributed in the US and four other countries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a diagnostic device that may produce inaccurate results (depressed recovery), which poses a risk of harm through misdiagnosis or treatment errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Abbott Laboratories, Inc. is recalling the Architect Magnesium assay (REF 7D70-21 and 7D70-31). The recall involves 24,995 units that were distributed nationwide in the United States and in China, Thailand, Guatemala, and El Salvador.
The recall was initiated after Abbott internal testing identified that the Magnesium urine application demonstrates depressed urine result recovery. Samples with concentrations greater than 0.5 mEq/L failed linearity acceptance criteria and showed depressed recovery of up to 37%. The specific cause of the negative bias is currently under investigation.
Healthcare facilities and laboratories should stop using the affected lots and contact Abbott for instructions on how to return the product. This recall is classified as Class II by the FDA.
The recalled product
- 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.
- Manufacturer
- Abbott Laboratories, Inc
- Affected units
- 24,995
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Abbott Laboratories, Inc
See all →- HighAbbott Alinity s System software error affects diagnostic analyzer wash cycle
FDA (Devices) · 2022-03-23
- HighAutomated diagnostic analyzer from Abbott recalled for waste pressure buildup
FDA (Devices) · 2021-08-18
- HighAbbott ARCHITECT C System Mixer Recall Due to Blade Separation Risk
FDA (Devices) · 2020-04-15
- ModerateAbbott APS Accelerator Modules Recalled for Missing Pacemaker Safety Label
FDA (Devices) · 2019-10-02
- ModerateAbbott Immunoglobulin G Diagnostic Assay Recall for IFU Updates
FDA (Devices) · 2019-07-31
Same hazard · inaccurate diagnostic result
See all →- HighSiemens Alkaline Phosphatase Reagent Cartridge Recall for Low Outlier Results
FDA (Devices) · 2020-10-28
- ModerateBinding Site Recalls VaccZyme Human Anti-Haemophilus Influenza Type B Assay Kits
FDA (Devices) · 2020-03-18
- HighInstrumentation Laboratory Recalls ROTEM ex-tem Kits Due to Prolonged Clotting Times
FDA (Devices) · 2019-09-18
- HighHelena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits
FDA (Devices) · 2019-07-17
- HighCSL Behring Recalls N Latex CDT Kits Due to Measurement Bias
FDA (Devices) · 2018-09-05