Device recall
Z-1135-2026: The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a…
FDA device recall · Class II · Beckman Coulter Ireland, Inc.
Key facts
| Recall number (Z-number) | Z-1135-2026 |
|---|---|
| Recall event | 98094 |
| Product | The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end… |
| Product code | LBS |
| Recalling firm | Beckman Coulter Ireland, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K040471 |
| FEI number | 1000206808 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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