CLASS II ONGOING Device recall · Reported 14 Aug 2024 · FDA Enforcement Report

Verigene Gram Positive Blood Culture (Bc-gp) Nucleic Acid Test recalled

Luminex is recalling Verigene Gram Positive Blood Culture (Bc-gp) Nucleic Acid Test, distributed nationwide in the US. The recall was initiated on 20 Jun 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024

Quantity recalled1,100 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2533-2024
FDA event ID: 94970
Recalling firm: Luminex, Northbrook, IL
Classification: Class II
Status: Ongoing
Recall initiated: 20 Jun 2024
FDA classified: 8 Aug 2024
Reported: 14 Aug 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Bacterial Contamination
Device type: Other Medical Devices

Timeline

20 Jun 2024	Recall initiated by company
8 Aug 2024	Classified by FDA	+49 days
14 Aug 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.

Product as listed by the FDA

Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

Where it was distributed

US Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, MS, NE, NV, OH, OK, SC, TN, TX, VA, VT, WA, WV.

Nationwide Arizona California Colorado Delaware Florida Georgia Iowa Illinois Kentucky Maryland Michigan Minnesota Missouri Mississippi Nebraska Nevada Ohio Oklahoma South Carolina Tennessee

Questions about this recall

Why was it recalled?

Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.

Which lots are affected?

GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024

Where was it sold?

US Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, MS, NE, NV, OH, OK, SC, TN, TX, VA, VT, WA, WV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Luminex

All 39

Reported	Class	Recall	Company	Reason	Where
11 Jun 2025Device	CLASS II	Verigene Gram Negative Blood Culture (Bc-gn) Nucleic Acid Test recalled	Luminex	Other	Nationwide
13 Dec 2023Device	CLASS II	Verigene Bc-gp Utility Tray Carrier) recalled by Luminex	Luminex	Device Malfunction	Nationwide
5 Jul 2023Device	CLASS II	Verigene Enteric Pathogens Nucleic Acid Test (EP) recalled by Luminex	Luminex	Other	Nationwide
5 Jul 2023Device	CLASS II	Verigene Clostridium difficile Nucleic Acid Test recalled by Luminex	Luminex	Other Bacterial Contamination	Nationwide
2 Nov 2022Device	CLASS II	Aries Sars-CoV-2 Assay recalled by Luminex	Luminex	Potency & Assay	Nationwide

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