FDA Device recall Z-3332-2026
Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 /…
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 /… by Beckman Coulter Mishima K K, citing certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3332-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-03 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Beckman Coulter Mishima K K |
| Distribution | US |
Product
Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B12183 / 14987666540671 The AU480 Chemistry Analyzer measure analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. This system is for in vitro diagnostic use only.
Reason
Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started. This causes a delay in obtaining patient results.
Identifiers
| code_info | Products containing affected software: Item Numbers / UDI-DI codes: Item Number: B96692 UDI-DI code: 14987666542965 It…Products containing affected software: Item Numbers / UDI-DI codes: Item Number: B96692 UDI-DI code: 14987666542965 Item Number: B96693 UDI-DI code: 14987666542972 Item Number: B12183 UDI-DI code: 14987666540671 Item Number: N3151400 UDI-DI code: Due to the age of the device and the fact that it has exceeded its storage period, the UDI number is not available.) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Beckman Coulter Mishima K K
- CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
FDA Device · Class II · 2026-03-18 · Beckman Coulter Mishima K K - DxC 700 AU, REF: B86444, B86446
FDA Device · Class II · 2026-03-18 · Beckman Coulter Mishima K K - Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette
FDA Device · Class II · 2025-06-11 · Beckman Coulter Mishima K K - Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette
FDA Device · Class II · 2025-06-11 · Beckman Coulter Mishima K K - DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination wit…
FDA Device · Class II · 2024-08-28 · Beckman Coulter Mishima K K
All Beckman Coulter Mishima K K recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3332-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.