Recall Z-2533-2024
Luminex Corporation · initiated June 20, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Codes / lots: GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024
Reason for recall
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
FDA-determined 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."
Details
- Recall number
- Z-2533-2024
- Initiated
- June 20, 2024
- Posted by FDA
- August 8, 2024
- Product code
- PAM – Gram-Positive Bacteria And Their Resistance Markers
- 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.
- Recalling firm
- Luminex Corporation, Northbrook, IL