AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Recall
- Recall Number
- Z-0692-2022
- Event Number
- 89178
- Firm
- Beckman Coulter Inc.
- FEI Number
- 2050012
- Product Code
- JGJ
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- December 8, 2021
- Terminated
- January 28, 2025
- Address
- 250 S Kraemer Blvd, Brea, CA, 92821-6232
Description
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
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.
On 12/08/2021, the firm sent recall notifications to customers via mail and e-mail. Customers with additional questions were encouraged to contact Customer Support: http://www.beckmancoulter.com or 1-800-223-0130 Action to be taken: "Retain a copy of this letter as it serves as current labeling. Where LIH influence check settings are enabled, customers must update the lipemia influence check settings on their AU/DxC AU analyzers. To determine if LIH influence check settings are enabled on your analyzer for Magnesium and to update your lipemia interference settings, perform the following action: DxC 700 AU: Select Menu List > Configuration Parameters > Specific Test Parameters > Test Volume and Methods > General > Edit. Update the LIH influence check for Magnesium Lipemia interference from +++++ to ++. AU480 / AU680 / AU5800: Select Menu > Parameters > Specific Test Parameters > General > Edit. Update the LIH influence check for Magnesium Lipemia interference from +++++ to ++. If LIH influence check settings are not enabled, review the new interference information in the IFU and assess whether changes are required to the reporting of magnesium results in the laboratory information system based on LIH flagging." Magnesium IFU (BAOSR6189) will be updated: The criteria for no significant interference is recovery within 10% or 0.29mg/dL (0.12mmol/L) of the initial value. Lipemia: No significant interference up to 200 mg/dL Intralipid The Magnesium setting sheet (BASOSR6189) will be updated so that the lipemia influence check setting is reduced from +++++ to ++. Please complete and return the response form.
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181,776 Kits