PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL,
Summary
The FDA issued a Class II for PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 7833 by Entopsis , Inc.. Reason: Presence of misleading label statements on the product label..
Details
Source
Device Recall
External ID
Z-1299-2023
Action Date
2023-04-05
Status
Ongoing
Category
device
Product Description
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
Lot/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, Exp. 05/2023; 20, Exp. 07/2023; 21, Exp. 07/2023; c) REF 78336100, Lot Numbers: 21, Exp. 07/2023
Quantity Affected: 397 units
Reason for Recall
Presence of misleading label statements on the product label.
Distribution
Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-21
Company
Medley, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Entopsis , Inc. has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Entopsis , Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Entopsis , Inc. have FDA actions?
Entopsis , Inc. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1299-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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