Z-2451-2021Class II

Verigene EP Amplification Reagent Kit Test

Name: Z-2451-2021 Verigene EP Amplification Reagent Kit Test
Creator: Luminex Corporation
Published: 2021-08-03
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2021-08-03 / Open, Classified / root cause: manufacturing process

FDA source

Luminex Corporation began a recall of Verigene EP Amplification Reagent Kit Test on 2021-08-03. FDA classified it as Class II and gives the reason as "There is potential for false positive results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2451-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-08-03
Posted: 2021-09-10
Recalling firm: Luminex Corporation
Product: Verigene EP Amplification Reagent Kit Test
Product code: PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Reason for recall: There is potential for false positive results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A customer letter was issued to notify consignees of the recall dated 08/03/2021. Customers are advised to notify Luminex if they are impacted by the recall and Luminex will facilitate replacement of the product. Customers are asked to destroy impacted product and document actions on a return response form.
Quantity in commerce: 4579 kits
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.
Product codes and lots: Model: Verigene Enteric Pathogens (EP) Stool PREP KIT; Catalog Number: 30-002-023; Lots: 111620023A 010421023A, 010621023D, 010721023E, 011121023A, 011221023D, 011821023A, 011921023D, 012521023A, 012821023D, 020921023D, 021021023E, 021721023D 022221023A, 030121023A, 030221023D, 030221023E, 030221023F, 030821023A, 030921023D, 031021023E, 031621023D, 031721023D, 032221023A, 032421023E, 032521023E, 033021023E, 040521023A, 041421023F, 041521023E, 042121023D, 042621023A, 050521023H, 050621023C, 051221023E, 051221023F, 111620023A, 111620023B, 111820023D, 111820023E, 112320023A, 112320023B, 120120023D, 120120023E, 120220023D, 120220023E, 120720023A, 120720023B, 120720023C, 120720023D, 120920023D, 120920023E, 120920023F, 121420023B, 121420023C, 121520023D, 121520023E, 121620023D, 121620023E, 122120023A, 122120023B,, 122220023D, 122220023E, 122820023A, 122820023B, 122920023D, 122920023E, 122920023F

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2451-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2451-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-10

Product code PCH

K140083Class IIVerigene Enteric Pathogen Nucleic Acid Test ( Ep)Nanosphere, Inc. / cleared 2014-06-20

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)