Recall Z-2451-2021 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Luminex Corporation
Verigene EP Amplification Reagent Kit Test
| Date | Aug 3, 2021 |
| Status | Open, Classified |
| Reason | There is potential for false positive results. |
| Root cause | Process control |
| Action | A customer letter was issued to notify consignees of the recall dated 08/03/2021. Customers are advised to notify Luminex if they are impacted by the recall and Luminex will facilitate replacement of the product. Customers are asked to destroy impacted product and document actions on a return response form. |
| Quantity | 4579 kits |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and 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 |