Device recall: VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results…
Class II FDA enforcement event 96701. Recall start date: . Status in the FDA record: Completed.
Reason for recall, in the words of FDA
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Luminex Corporation started this device recall on 16 Apr 2025. The firm address in the FDA record is in Northbrook, IL. FDA put the recall in Class II. FDA event 96701 has 1 product record. The first FDA enforcement report date is 11 Jun 2025. The record gives the status Completed.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
Recalling firm
Luminex Corporation, Northbrook, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1903-2025 | VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test | 89 units | Class II | Completed | 11 Jun 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 24
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Jun 2024 | Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test | Device | Class II | 1 |
| 7 Nov 2023 | Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a c | Device | Class II | 1 |
| 5 Jun 2023 | Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 | Device | Class II | 2 |
| 14 Sep 2022 | ARIES SARS-CoV-2 Assay, REF: 50-10047 | Device | Class II | 1 |
| 14 Jul 2022 | ARIES SARS-CoV-2 Assay | Device | Class II | 1 |
| 17 Jun 2022 | Verigene CDF Nucleic Acid Test, Part No. 30-002-22 | Device | Class II | 2 |
| 5 Apr 2022 | Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system | Device | Class II | 1 |
| 15 Feb 2022 | VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 | Device | Class II | 1 |
| 17 Nov 2021 | ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 | Device | Class II | 1 |
| 3 Aug 2021 | Verigene EP Amplification Reagent Kit Test | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1903-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 96701. https://recallregister.com/fda/ii/96701/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
- What quantity of product is in FDA event 96701?
- The FDA record gives this quantity:
89 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.