Recall Z-2533-2024 ยท PAM Gram-Positive Bacteria And Their Resistance Markers
Luminex Corporation
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
| Date | Aug 8, 2024 (initiated Jun 20, 2024) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122514 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST Nanosphere, Inc., Sep 19, 2012 |