Recall Z-0877-2022 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Hologic, Inc
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
| Date | Apr 6, 2022 (initiated Mar 18, 2022) |
| Status | Open, Classified |
| Reason | Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results. |
| Root cause | Component change control |
| Action | On 03/18/22, recall notices were sent to customers who were informed that the recalling firm is discontinuing the further sale of the affected GBS Assay for the foreseeable future. Customers were asked to do the following: 1) Discontinue use and destroy affected GBS assay kit lots and respective components. 2) Complete and return the customer response form. Customers with additional questions were encouraged to contact Technical Support at +1 888 484 4747 or +1 858 410 8511 between 5am PDT and 5 pm PDT, or by email at molecularsupport@hologic.com |
| Quantity | 2061 |
| Distribution | US: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI, PR OUS: CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181156 | Panther Fusion GBS Assay Diagenode, Jul 27, 2018 |