Recall Z-2428-2024— Beckman Coulter Inc.
Class II · Ongoing
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2024-05-27. It names one FDA 510(k) clearance: K073487. Product: Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2. Reason: LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal.
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-27
- 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
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Reason for recall
LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal
Data sourced from openFDA. This site is unofficial and independent of the FDA.