Device type
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Product code JJE · Class I · 21 CFR 862.2160 · Clinical Chemistry
Recent 510(k)s
No 510(k) clearances in the archive for JJE.
Recent recalls
Oct 14, 2026
Z-0083-2027
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, D…
Beckman Coulter Inc.
- JJE
- Class II
- Ongoing
Oct 14, 2026
Z-0084-2027
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Beckman Coulter Inc.
- JJE
- Class II
- Ongoing
Oct 7, 2026
Z-3332-2026
Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B121…
Beckman Coulter Mishima K.K.
- JJE
- Class II
- Ongoing
Aug 26, 2026
Z-2974-2026
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520;…
Beckman Coulter Inc.
- JJE
- Class II
- Ongoing
Aug 26, 2026
Z-2973-2026
Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU…
Beckman Coulter Inc.
- JJE
- Class II
- Ongoing