Recall Z-0692-2022— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2021-12-08, terminated 2025-01-28. It names one FDA 510(k) clearance: K944407. 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..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-12-08
- Terminated
- 2025-01-28
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.