Device recall
Z-0002-2027: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS…
FDA device recall · Class I · Instrumentation Laboratory
Key facts
| Recall number (Z-number) | Z-0002-2027 |
|---|---|
| Recall event | 99843 |
| Product | HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only) |
| Product code | LCO |
| Recalling firm | Instrumentation Laboratory |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K170854 |
| FEI number | 1217183 |
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