FDA Device recall Z-2428-2024
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
- FDA Device
- Class II
- ongoing
- Published 2024-07-31
On 2024-07-31 the FDA classified a Class II recall of Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 by Beckman Coulter, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2428-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-27 |
| Published | 2024-07-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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
Identifiers
| code_info | UDI: 15099590011598/ All Lots: 2548/Exp. 2024-06-01, 2549/Exp.2024-10-01, 2550/Exp. 2024-11-01, 2551/Exp. 2025-04-01, 2…UDI: 15099590011598/ All Lots: 2548/Exp. 2024-06-01, 2549/Exp.2024-10-01, 2550/Exp. 2024-11-01, 2551/Exp. 2025-04-01, 2552/Exp. 2025-07-01, 2553/Exp. 2025-10-01, 2554/ Exp. 2026-03-01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2428-2024%22
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