Device recall
Z-1372-2019: Lipid Panel test strips (as a component of smart bundles), REF 2729, also…
FDA device recall · Class II · Polymer Technology Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1372-2019 |
|---|---|
| Recall event | 82331 |
| Product | Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412 |
| Product code | CHH |
| Recalling firm | Polymer Technology Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 24, 2020 |
| 510(k) numbers | K023558 |
| 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