Device recall
Z-1249-2021: RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage…
FDA device recall · Class II · Medline Industries Inc
Key facts
| Recall number (Z-number) | Z-1249-2021 |
|---|---|
| Recall event | 87232 |
| Product | RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement. |
| Product code | JPK |
| Recalling firm | Medline Industries Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 9, 2023 |
| 510(k) numbers | K853776 |
| FEI number | 1417592 |
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