Device recall
Z-0283-2020: Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN…
FDA device recall · Class II · Randox Laboratories Ltd.
Key facts
| Recall number (Z-number) | Z-0283-2020 |
|---|---|
| Recall event | 83791 |
| Product | Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin… |
| Product code | JIX |
| Recalling firm | Randox Laboratories Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 8, 2021 |
| 510(k) numbers | K061056 |
| FEI number | 1000361607 |
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