Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid… recallZ-2533-2024 · Luminex Corporation · initiated Jun 20, 2024
Open, Classified
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
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
FDA root cause category: Under Investigation by firm
What the company is doing
Diasorin sent a recall notification on 06/20/2024, via email. Consignees were instructed to examine inventory and quarantine any affected units, arrange for replacement and confirm disposal of any of affected units on hand. Customers were asked to perform a retrospective review of results for VERIGENE Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) to look for any false positives, distribute the notification to any relevant personnel, notify consignees if further distributed and complete and return the "Acknowledgement & Receipt Form."
Recall details
- Recall number
- Z-2533-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 20, 2024
- Posted by the FDA
- Aug 8, 2024
- Recalling firm
- Luminex Corporation
- Quantity
- 1,100 kits
- Product code
- PAM
- FDA submissions
- K122514
- Distribution
- 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.
Product description
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Code information (models, lots, serial numbers)
GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge 20-006-018Luminex Corporation · Gram-positive bacteria and their resistance markers1 recall1 death15 reports
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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