Hologic, Inc Recall 89855
Description: Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Hologic, Inc Recall 89855 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0877-2022 |
| Event ID | 89855 |
| Event Description | Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus. |
| Product Type | Devices |
| 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 |
| Quantity | 2061 |
| Recall 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. |
| Device Classification | 20220413 |
| Device Code Info | UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353 |
| Center Classification Date | 20220406 |
| Recall Initiation Date | 20220318 |
| Recalling Firm | Hologic, Inc |
| Initial Notification | Letter |
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