Recall Z-1488-2021 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Luminex Corporation
VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
| Date | Mar 18, 2021 |
| Status | Open, Classified |
| Reason | Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit. |
| Root cause | Process control |
| Action | A customer advisory notice dated 03/18/2021. The Customer Advisory Notice recommends customers review their QC data to ensure passing results for all VERIGENE EP test targets, and to contact Luminex if any false negatives are observed for any targets within the past twelve months, in order to arrange for a replacement of the Amplification Heater. Additionally, if a Processor SP unit is indicated to have received service 15 on the TSB Log, the Amplification Heater would have already been replaced under routine maintenance with an in specification Amplification Heater and no further action is re |
| Quantity | 1210 Units |
| Distribution | Worldwide distribution - United States (nationwide) and the countries of Austria, France, Greece, Japan, Netherlands, Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140083 | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) Nanosphere, Inc., Jun 20, 2014 |