CLASS II ONGOING Device recall · Reported 14 Jul 2021 · FDA Enforcement Report

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

Luminex is recalling Verigene Gram-Positive Blood Culture Nucleic Acid Test (Bc-gp), distributed nationwide in the US. The recall was initiated on 30 Oct 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes030620018A, 031420018A, 032020018A, 040120018A, 041020018B, 041720018B, 042420018A, 043020018A, 050220018A, 050720018A, 050920018A, 051320018A, 051420018A, 051520018A, 052020018A,052120018A, 052920018A, 060220018A, 060920018A, 061020018A, 061620018A, 061920018D, 062020018A, 062620018A, 063020018A, 070720018A, 071620018A, 072320018A, 073020018A, 080520018A, 082020018A, 082520018A, 082820018A, and 090120018A

Quantity recalled36,416

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-2007-2021
FDA event ID: 88137
Recalling firm: Luminex, Northbrook, IL
Classification: Class II
Status: Ongoing
Recall initiated: 30 Oct 2020
FDA classified: 2 Jul 2021
Reported: 14 Jul 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Oct 2020	Recall initiated by company
2 Jul 2021	Classified by FDA	+245 days
14 Jul 2021	Published in enforcement report	+12 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 a false-negative result.

Product as listed by the FDA

Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018

Where it was distributed

Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.

Nationwide Alabama Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan

Questions about this recall

Why was it recalled?

Potential for a false-negative result.

Which lots are affected?

030620018A, 031420018A, 032020018A, 040120018A, 041020018B, 041720018B, 042420018A, 043020018A, 050220018A, 050720018A, 050920018A, 051320018A, 051420018A, 051520018A, 052020018A,052120018A, 052920018A, 060220018A, 060920018A, 061020018A, 061620018A, 061920018D, 062020018A, 062620018A, 063020018A, 070720018A, 071620018A, 072320018A, 073020018A, 080520018A, 082020018A, 082520018A, 082820018A, and 090120018A

Where was it sold?

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.

Other products in this recall event

5 other products · FDA event 88137

This product is part of a recall event; the main page for the event is Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) recalled.

Reported	Class	Recall	Company	Reason	Where
14 Jul 2021	CLASS II	Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) recalled	Luminex	Other	Nationwide
14 Jul 2021	CLASS II	Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-gn) recalled	Luminex	Other	Nationwide
14 Jul 2021	CLASS II	Verigene Enteric Pathogens Nucleic Acid Test (EP) recalled by Luminex	Luminex	Other	Nationwide
14 Jul 2021	CLASS II	Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) recalled	Luminex	Other Bacterial Contamination	Nationwide
14 Jul 2021	CLASS II	Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) recalled	Luminex	Other	Nationwide

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
14 Aug 2024Device	CLASS II	Verigene Gram Positive Blood Culture (Bc-gp) Nucleic Acid Test recalled	Luminex	Other Bacterial Contamination	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

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All 13,778

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