# FDA recall Z-0692-2022

> **Beckman Coulter Inc.** · Class II · device recall initiated 2021-12-08.

## Product

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

## 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.

## 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, Ital

## Key facts

- **Recall number:** Z-0692-2022
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-08
- **Report date:** 2022-03-09
- **Termination date:** 2025-01-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0692-2022

## Citation

> AI Analytics. FDA recall Z-0692-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0692-2022. Source: US FDA. Licensed CC0.

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