PCR Reagent Recalled for Misleading Label Statements
Entopsis, Inc. is recalling 397 units of PCRopsis Reagent RVD with RVD Enhancer due to misleading label statements. The affected products were distributed nationwide and internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for labeling errors with no reported illnesses, injuries, or deaths. Per the rubric, minor labeling errors and voluntary precautionary recalls are classified as score 2 (Moderate).
Plain-English summary
Entopsis, Inc. is recalling 397 units of PCRopsis Reagent RVD with RVD Enhancer, a PCR reagent used for extraction-free nucleic acid detection from saliva, urine, swab specimens in transport medium, and other biological samples. The recall affects three package sizes: 1 mL (validation use only, REF 78336001), 25 mL (REF 78336025), and 100 mL (REF 78336100).
The product label contains misleading statements. The FDA recall notice does not specify the nature of these misstatements.
The recalled products were distributed nationwide and to international markets including Canada, United Kingdom, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania. Specific lot numbers are affected with expiration dates in May and July 2023: Lots 18, 20, and 21 for the 1 mL and 25 mL sizes, and Lot 21 for the 100 mL size.
Holders of the affected products should contact Entopsis, Inc. for guidance on corrected labeling and product replacement or return options.
The recalled product
- 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
- Manufacturer
- Entopsis , Inc.
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- a) REF 78336001
- Lot Numbers: 18
- Exp. 05/2023
- 20
- Exp. 07/2023
- 21
- b) REF 78336025
- c) REF 78336100
- Lot Numbers: 21
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27