Device recall
Z-0999-2023: R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF…
FDA device recall · Class III · R & D Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0999-2023 |
|---|---|
| Recall event | 91136 |
| Product | R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Controls L, N, and H; (3) CBC-3D for Mythic 18 Hematology Control, REF 3D503RX, containing 2 x 2.0 mL each… |
| Product code | JPK |
| Recalling firm | R & D Systems, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 26, 2026 |
| 510(k) numbers | K843962 |
| FEI number | 2182501 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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