Device recall
Z-3332-2026: Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY…
FDA device recall · Class II · Beckman Coulter Mishima K.K.
Key facts
| Recall number (Z-number) | Z-3332-2026 |
|---|---|
| Recall event | 99588 |
| 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… |
| Product code | JJE |
| Recalling firm | Beckman Coulter Mishima K.K. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K981743 |
| FEI number | 3002807663 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database