—#190712

Product

AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850

FDA product code: JGJ — Photometric Method, Magnesium
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K944407
Affected lot / code info: All lot numbers.

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: US: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming; and OUS: Albania, Algeria, American Samoa, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Ethiopia, Finland ,France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Guyana, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lesotho, Libya, Lithuania, Macau, Macedonia, Malawi, Malaysia, Mayotte, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Niger, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saint Pierre and Miquelon, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam, Yemen, Zambia, Zimbabwe.

Timeline

Recall initiated: 2021-12-08
Terminated: 2025-01-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190712. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.