Z-1299-2023Class II

PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025...

Name: Z-1299-2023 PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025...
Creator: Entopsis , Inc.
Published: 2023-02-21
License: https://open.fda.gov/license/

Entopsis, Inc. / initiated 2023-02-21 / Open, Classified / root cause: labeling and UDI

FDA source

Entopsis , Inc. began a recall of 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... on 2023-02-21. FDA classified it as Class II and gives the reason as "Presence of misleading label statements on the product label". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1299-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-21
Posted: 2023-03-29
Recalling firm: Entopsis, Inc.
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
Product code: JJH Clinical Sample Concentrator
Reason for recall: Presence of misleading label statements on the product label.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm issued a MEDICAL DEVICE RECALL notice to its consignees on 02/21/22023 by email. Those without a valid email address were mailed the notice via certified mail. The notice explained the issue and risk and requested the customer/user take the following actions: "Entopsis Inc., requests that the product lots listed below - shipped/received before February 8st, 2023 be promptly discontinued from use and discarded from inventory as per your non-hazardous waste disposal plan.The labeling of PCRopsis products was revised on February 8th, 2022. Updated statements of intended use and revised instructions for use are available on www.pcropsis.com. If you are currently using or intend to use the PCRopsis product lots affected by this recall please contact us at [email protected] or 1-888-407-5070 (Monday to Friday 9.00 AM to 4.30 PM Eastern Time) to request a replacement. If you are a re-distributor of PCRopsis devices, notify your end customer with a copy of this letter. Please acknowledge the removal of affected product lots by filling out the attached acknowledgment form and returning it to us at [email protected]. Contact us at [email protected] or 1-888-407-5070 - Monday to Friday 9.00 AM to 4.30 PM US Eastern Time (GMT -5) with any questions you may have."
Quantity in commerce: 397 units
Distribution: Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1299-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1295-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-29
Z-1296-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-29
Z-1297-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-29
Z-1298-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-29
Z-1299-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-29
Z-1300-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-29
Z-1301-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-29

Product code JJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)