Device recall
Z-0039-2013: IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging…
FDA device recall · Class II · Immunodiagnostics Systems Ltd
Key facts
| Recall number (Z-number) | Z-0039-2013 |
|---|---|
| Recall event | 62968 |
| Product | IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine… |
| Product code | JMM |
| Recalling firm | Immunodiagnostics Systems Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2012 |
| FEI number | 3002485711 |
At a glance
- None 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