Z-0692-2022Class II

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

Name: Z-0692-2022 AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Creator: Beckman Coulter Inc.
Published: 2021-12-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-12-08 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc. began a recall of AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850 on 2021-12-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0692-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-08
Posted: 2022-02-28
Terminated: 2025-01-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Product code: JGJ Photometric Method, Magnesium
Reason for recall: 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 tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 181,776 Kits
Distribution: 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.
Product codes and lots: All lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0692-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0692-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-02-28

Product code JGJ

K944407Class IOlympus Magnesium ReagentOlympus America, Inc. / cleared 1994-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)