AU/DxC AU Magnesium Test Kits Recalled Due to Measurement Error in Lipemic Samples
Beckman Coulter is recalling 181,776 AU/DxC AU Magnesium test kits because the test may give falsely elevated results in lipemic samples, potentially affecting clinical interpretation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II medical device recall involving measurement inaccuracy under specific conditions. No illnesses, injuries, or deaths have been reported. Per the rubric, this qualifies as a risk-of-harm product without documented injury, placing it at Score 3.
Plain-English summary
Beckman Coulter Inc. is recalling 181,776 AU/DxC AU Magnesium test kits (Catalog/REF Number OSR6189, UDI 15099590010850). The test kits failed to meet performance standards for lipemic samples—samples with elevated blood lipids. When lipemia is present, the test can produce falsely elevated magnesium results, with a maximum positive bias of 30.38% in low magnesium samples.
This measurement error affects only the clinical interpretation of magnesium results in patients with elevated lipids. Healthcare providers using affected test kits should be aware that magnesium results may be overestimated in lipemic samples, potentially leading to misinterpretation of a patient's magnesium status.
The affected kits were distributed throughout the United States and to multiple countries worldwide. All lot numbers of this product are subject to the recall.
The recalled product
- Product
- AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 181,776
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbers.
Distribution
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