FDA Medical Device Recalls (openFDA)
Luminex Corporation: Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
- Recall number
- Z-2533-2024
- Recalling firm
- Luminex Corporation
- Product
- Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
- Status
- Open, Classified
- Initiated
- 2024-06-20
- Posted
- 2024-08-08
- Terminated
- not on file
- Reason
- Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
- Root cause
- Under Investigation by firm
- Action
- 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."
- Quantity
- 1,100 kits
- 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.
- Lot, serial or model codes
- GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024
- 510(k) numbers
- ["K122514"]
- PMA numbers
- not on file
- Product code
- PAM
- Firm FEI
- 3006028115
- Firm city
- Northbrook
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28