Recall Z-0692-2022 ยท JGJ Photometric Method, Magnesium
Beckman Coulter Inc.
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
| Date | Dec 8, 2021 |
| Status | Terminated |
| Reason | 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 | 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 acti |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944407 | OLYMPUS MAGNESIUM REAGENT Olympus America, Inc., Dec 27, 1994 |