Device recall
Z-1100-06: Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No…
FDA device recall · Class II · Applied Biotech Inc
Key facts
| Recall number (Z-number) | Z-1100-06 |
|---|---|
| Recall event | 35542 |
| Product | Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp 02/10/2007 |
| Product code | JHI |
| Recalling firm | Applied Biotech Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 29, 2012 |
| 510(k) numbers | K992187 |
| FEI number | 1000125390 |
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