FDA Device recall Z-1299-2023
PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001
- FDA Device
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001 by Entopsis, citing presence of misleading label statements on the product label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1299-2023 |
| 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 Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples
Reason
Presence of misleading label statements on the product label.
Identifiers
| code_info | a) REF 78336001, Lot Numbers: 18, Exp. 05/2023; 20, Exp. 07/2023; 21, Exp. 07/2023; b) REF 78336025, Lot Numbers: 18…a) REF 78336001, Lot Numbers: 18, Exp. 05/2023; 20, Exp. 07/2023; 21, Exp. 07/2023; b) REF 78336025, Lot Numbers: 18, Exp. 05/2023; 20, Exp. 07/2023; 21, Exp. 07/2023; c) REF 78336100, Lot Numbers: 21, Exp. 07/2023 |
|---|
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-1299-2023%22
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