FDA Device recall Z-0692-2022
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
- FDA Device
- Class II
- terminated
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850 by Beckman Coulter, citing 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 magn….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0692-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-08 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
Product
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
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.
Identifiers
| code_info | All lot numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0692-2022%22
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