Recall Z-0822-2019 ยท PAM Gram-Positive Bacteria And Their Resistance Markers
Luminex Corporation
Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed d
| Date | Feb 11, 2019 (initiated Dec 26, 2018) |
| Status | Terminated |
| Reason | On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label. |
| Root cause | Under Investigation by firm |
| Action | The firm, Luminex, notified the consignees by email with a letter entitled "URGENT: MEDICAL DEVICE RECALL" dated 12/20/2018 on 12/26/2018. The letter described the product, problem and actions to be taken. The customers were instructed to: Please check your VERIGENE BC-GP Utility Kit inventory to determine if you have any of the listed products; if product(s) is (are) located within your inventory, please follow the instructions and information about destroying any found recalled product at your facility, and complete and return Acknowledgment and Receipt form an email, and send it on or befo |
| Quantity | 1132 carriers |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Austria, and 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 |