Reported Mar 9, 2022 · Terminated
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
AU/DxC AU MagnesiumCatalog/REF Number OSR6189UDI 15099590010850
- Lot codes and dates
- All lot numbers.
- Amount recalled
- 181,776 Kits
Where it was sold
Why it was recalled
Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is only to the clinical interpretation of magnesium results in the presence of lipemia.
This product could cause temporary or reversible health problems — stop using it.
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