Recall Z-0877-2022— Hologic, Inc
Class II · Ongoing
Class II FDA medical device recall by Hologic, Inc, initiated 2022-03-18. It names one FDA 510(k) clearance: K181156. Product: Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.. 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..
- Recalling firm
- Hologic, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-18
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.