FDA Device recall Z-1295-2023
PCRopsis BCSNano (1mL), REF 2276001
- FDA Device
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of PCRopsis BCSNano (1mL), REF 2276001 by Entopsis, citing presence of misleading label statements on the product label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1295-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-21 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Entopsis |
| Distribution | US |
Product
PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
Reason
Presence of misleading label statements on the product label.
Identifiers
| code_info | Lot number 3, Exp. 11/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1295-2023%22
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