Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a c

FDA device recall Z-0500-2024 · posted 2023-12-06 · Open, Classified

Recall details

Recalling firm

Luminex Corporation

Reason for recall

Potentially defective utility trays in the reagent kits.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PAM

Quantity affected

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.

Date initiated

2023-11-07

Date posted

2023-12-06

Location

Northbrook, IL

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