The Recall Desk
HighFDA (Devices)·Z-0692-2022·Announced 2022-03-09

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.

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: 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.
Category
Medical Device — Laboratory Test Reagent
Hazard
  • measurement-error
  • lipemia-interference

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

Distribution scope not specified by the agency.

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