Beckman Coulter Inc. Recall 89178
Description: AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Beckman Coulter Inc. Recall 89178 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0692-2022 |
| Event ID | 89178 |
| Event Description | AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850 |
| Product Type | Devices |
| 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. |
| Quantity | 181,776 Kits |
| Recall 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. |
| Device Classification | 20220309 |
| Device Code Info | All lot numbers. |
| Center Classification Date | 20220228 |
| Recall Initiation Date | 20211208 |
| Recalling Firm | Beckman Coulter Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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