Device recall
Z-1193-2012: PointCare NOW CD4NOW Gold Reagent Pack, or Gold Pack, Part Number:30034 In…
FDA device recall · Class II · Pointcare Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-1193-2012 |
|---|---|
| Recall event | 61092 |
| Product | PointCare NOW CD4NOW Gold Reagent Pack, or Gold Pack, Part Number :30034 In Vitro Diagnostic : Assay reagent intended for use on the PointCare NOW In Vitro Diagnostics Instrument to provide CD4 positive lymphocytes cell count |
| Product code | GKZ |
| Recalling firm | Pointcare Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 26, 2012 |
| 510(k) numbers | K072869 |
| FEI number | 3004086182 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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