Recall Z-0500-2024 ยท PAM Gram-Positive Bacteria And Their Resistance Markers
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.
| Date | Dec 6, 2023 (initiated Nov 7, 2023) |
| Status | Open, Classified |
| 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 res |
| 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. |
| 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 |