Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococ
FDA device recall Z-0877-2022 · posted 2022-04-06 · Open, Classified
Recall details
- Recalling firm
- Hologic, Inc
- Reason for recall
- Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
- Action taken
- 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
- Root cause
- Component change control
- Status
- Open, Classified
- Product code
- NJR
- Quantity affected
- 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
- Date initiated
- 2022-03-18
- Date posted
- 2022-04-06
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Panther Fusion GBS Assay (K181156) | Diagenode | 2018-07-27 |