PCRopsis Reagent RVD-RT in vitro diagnostic kit recall for misleading labels

Plain-English summary

Entopsis, Inc. is recalling PCRopsis Reagent RVD-RT, an in vitro diagnostic kit used for extraction-free PCR at room temperature and nucleic acid extraction from biological samples, due to misleading label statements on the product label.

Misleading labels on diagnostic reagents could lead to improper use, incorrect interpretation of test results, or suboptimal sample handling. No illnesses or injuries have been reported.

The recall affects 97 units distributed nationwide and internationally to Canada, UK, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania. Affected lot numbers are: REF 78378001 (1 mL, Lot 4 Exp. 02/2023 and Lot 7 Exp. 07/2023), REF 78378025 (25 mL, Lot 6 Exp. 06/2023), and REF 78378100 (100 mL, Lot 7 Exp. 07/2023).

Consumers who have purchased affected lots should stop using the product and contact Entopsis, Inc. for replacement or refund instructions.

The recalled product

Product

PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples

Manufacturer

Entopsis , Inc.

Category

Medical Device — Diagnostic Reagent

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.

Distribution

Distributed nationwide across the United States.

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