FDA Device recall Z-1815-2025
Apo B Reagent, REF: OSR6143
- FDA Device
- Class III
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class III recall of Apo B Reagent, REF: OSR6143 by Beckman Coulter Ireland, citing the product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B pa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1815-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-04-23 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter Ireland |
| Distribution | US |
Product
Apo B Reagent, REF: OSR6143
Reason
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
Identifiers
| code_info | Lot # 2631/UDI: 15099590010409 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2025-12-31 · Beckman Coulter Ireland
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1815-2025%22
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