FDA Device recall Z-0837-2024
Terragene Bionova PCD (PCD222-C)
- FDA Device
- Class II
- ongoing
- Published 2024-02-07
On 2024-02-07 the FDA classified a Class II recall of Terragene Bionova PCD (PCD222-C) by Terragene, citing due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0837-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-07 |
| Published | 2024-02-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Terragene |
| Distribution | US |
Product
Terragene Bionova PCD (PCD222-C)
Reason
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Identifiers
| code_info | Product Number: Terragene Bionova PCD (PCD222-C) UDI-DI code: 07798164676027 Serial Numbers: F20002 F20021 F20046 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0837-2024%22
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