Device recall
Z-2158-2019: Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref…
FDA device recall · Class III · Polymer Technology Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2158-2019 |
|---|---|
| Recall event | 83097 |
| Product | Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus… |
| Product code | CHH |
| Recalling firm | Polymer Technology Systems, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 8, 2020 |
| 510(k) numbers | K151545 |
| FEI number | 3015525148 |
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