FDA Medical Device Recalls (openFDA)
Luminex Corporation: Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
- Recall number
- Z-0500-2024
- Recalling firm
- Luminex Corporation
- Product
- Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
- Status
- Open, Classified
- Initiated
- 2023-11-07
- Posted
- 2023-12-06
- Terminated
- not on file
- Reason
- Potentially defective utility trays in the reagent kits.
- Root cause
- Under Investigation by firm
- Action
- The recalling firm issued letters dated 11/7/2023 via email on the same date. The letter explained the reason for recall, risk to health, and actions to be taken by the consignee/distributor. The actions included examining their inventory for the affected product, cease all use, and isolate or quarantine the product pending disposal; contact Luminex Global Support Services to arrange for replacement and confirm the disposal of any remaining kits in inventory; perform a retrospective review of results for VERIGENE Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) and if false negative results with a patient sample tested with the affected lot number have been encountered, contact Luminex Global Support; distribute the notification to any individuals within their organization who need to be made aware of the recall; if the consignee is a distributor, they are to provide a copy of this letter to any customers or organizations who may have received the affected lot number; and complete the enclosed Acknowledgement & Receipt Form and return it to Luminex Technical Support.
- Quantity
- 222 kits (4,440 trays)
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GL, IL, IN, MA, MD, MI, MN, MO, MS, NE, NY, OH, OK, OR, TN, TX, UT, VA, WA, and WI. The country of Italy.
- Lot, serial or model codes
- Lot number 062123018C, Exp. 12/20/2023, UDI (01)00840487101674(17)231220(10)062123018C.
- 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