Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
- Company
- Luminex Corporation
- Recall Initiated
- June 20, 2024
- Posted
- August 8, 2024
- Recall Number
- Z-2533-2024
- Quantity
- 1,100 kits
- Firm Location
- Northbrook, IL
Reason for Recall
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
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 / Code Info
GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024
Root Cause
Under Investigation by firm
Action Taken
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."