Device recall
Z-1531-2015: MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing…
FDA device recall · Class II · Beckman Coulter, Inc.
Key facts
| Recall number (Z-number) | Z-1531-2015 |
|---|---|
| Recall event | 70893 |
| Product | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 55, Catalog B1017-409 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint… |
| Product code | JWY |
| Recalling firm | Beckman Coulter, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2015 |
| 510(k) numbers | K870074 |
| FEI number | 2919016 |
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