VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid… recallZ-1903-2025 · Luminex Corporation · initiated Apr 16, 2025
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Luminex Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Diasorin issued an Urgent Field Safety Notice to its consignees on 04/16/2025 via email. The notice explained the issue, potential risk to health, and requested the following: "Actions to be taken by the Customer/User 1. Please examine your inventory for the affected products, cease all use, and isolate or quarantine them pending disposal. 2. If you currently have any of the identified affected barcode serial numbers from VERIGENE BC-GN Nucleic Acid Test Cartridge, Lot 022525021A, please contact Technical Support at [email protected] to arrange for replacement and confirm the disposal of any remaining tests in your inventory per the package insert disposal guidelines. 3. Perform a retrospective review of results for VERIGENE Gram-Negative Blood Culture Nucleic Acid Test (BC-GN). If you have encountered a false negative result with a patient sample tested with the potentially impacted portion of Lot 022525021A, please contact Technical Support at [email protected]. 5. If you are a distributor, provide a copy of this letter to any customers or organizations who may have received VERIGENE BC-GN Nucleic Acid Test Cartridge, Lot 022525021A. 6. Please complete the Acknowledgement & Receipt Form and return it to Technical Support. 7. For those with complaints, questions, or concerns please contact Technical Support at 1-877-785-2323 (U.S) or +1-512-381-4397 (Outside U.S.)."
Recall details
- Recall number
- Z-1903-2025
- Status
- Completed
- Initiated by the company
- Apr 16, 2025
- Posted by the FDA
- Jun 3, 2025
- Recalling firm
- Luminex Corporation
- Quantity
- 89 units
- Product code
- PEN
- FDA submissions
- K132843
- Distribution
- US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
Product description
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
Code information (models, lots, serial numbers)
UDI/DI 00840487101599, Lot Number 022525021A, exp. 08/26/2025
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge 20-006-021Luminex Corporation · Gram-Negative bacteria and associated resistance markers1 recall1 death15 reports
Other devices under the same FDA submission
2 devices cleared under K132843 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge 20-006-021Nanosphere, Inc. · Gram-Negative Bacteria And Associated Resistance Markers2 deaths2 reports
- Gram-Negative Blood Culture (BC-GN) Utility Tray 20-011-021Luminex Corporation · Gram-Negative bacteria and associated resistance markers1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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