Every recall we track for Hologic, Inc — 33 in all — plus the complaints and injury reports the public filed about them.
Hologic recalls 3D mammography systems with model numbers 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, etc. due to loose, missing or broken internal bolts that could affect safety.
Hologic recalls SELENIA Dimensions Mammography Systems with model numbers SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, and others due to loose, missing, or broken internal bolts that could affect system stability.
Hologic recalls Genius Review Station Display (model CMP-016:01669) due to user modifications causing safety risks. Affected users should stop using modified devices until corrected.
Hologic recalls Aptima HPV Assay Kit (model 303585) due to potential for false negatives. Affected kits may give incorrect results, leading to missed diagnoses. Contact Hologic for details.
Hologic recalls Brever: Particulates in disposable 9 gauge biopsy needles may deposit in breast tissue during use. Affected units include all lots within expiry date.
Hologic recalls ThinPrep CytoLyt Solution due to fungal contamination in specific lots. Affected units may pose health risks if used improperly.
Hologic recalls Sertera-14 biopsy devices due to risk of inner needle separating from hub, potentially causing dislodgement. Affected units include specific model numbers and lot codes.
Hologic recalls specific lots of Rapid fFN Specimen Collection Tubes that may be empty or underfilled, causing invalid test results for preterm delivery risk assessment.
Hologic recalls Panther Fusion GBS Assay REF PRD-04484 Kit due to potential weak pouch seal causing invalid test results, which may delay treatment. Affected kits have specific lot numbers and expiration dates.
Hologic recalls Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay kits that may give false positive results for SARS-CoV-2. Affected kits have specific lot numbers and expiration dates.
Hologic recalls BioZorb Marker radiographic soft tissue markers due to serious injuries like pain, infection, and device migration. Affected models include F0405, F0404, and others. Contact Hologic for details.
Hologic recalls specific software versions for breast tomosynthesis systems that may produce blurry images when used with C-View software, potentially causing false negative diagnoses. Affected users should contact Hologic for updates.
Hologic recalls Horizon X-Ray Bone Densitometer (DXA) models Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN due to electromagnetic compatibility issues with international medical standards. Affected units have serial numbers listed in the recall notice.
Hologic recalls BioZorb 3D bioabsorbable markers used in breast procedures due to reported pain, infection, and device complications. Affected models include F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, F0202.
Hologic recalls Panther Fusion System REF 9121010000 due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. Affected units may need replacement.
Hologic recalls Aptima CMV Quant Assay reagents (AW-22600-001, AW-25509-001, AW-26381-001) due to potential error codes when used with plasma specimens. Affected units may invalidate samples.
Hologic recalls Sertera 14 Gauge Biopsy Devices due to potential needle detachment causing surgery delays. Affected devices have specific lot numbers and UDI-DI codes.
Hologic recalls specific models of 3D medical C-Arms due to risk of unexpected movement causing blunt trauma. Affected units include RM-SDM-00001-3D and other models with serial numbers listed. Contact Hologic for details.
Hologic recalls sterilization trays and sizers due to missing instructions. Owners should check model numbers and lot dates to determine if affected. No immediate action needed but ensure proper use.
Hologic recalls BioZorb LP markers with expired labels that show incorrect dates. The product may be used incorrectly due to outdated expiration dates on removable labels.
Hologic recalls Panther Fusion GBS Assay Cartridges (96 tests) due to potential false negative results when analyte concentrations are near detection limits. Affected lots include 274954, 284599, 296991, 300796, 309230, 309353.
Hologic recalls Panther Fusion Extraction Reagent-X (lot 281375, 291829) due to potential false negative test results. Affected kits may not detect diseases correctly.
Hologic recalls 18-count Panther Fusion Tube Trays (PN: FA-15004) that may leak, causing false positive/negative test results. Affected units sold with specific lot numbers.
Hologic recalls Panther Fusion Tube Tray (FAB-15004) due to potential leaks causing false negative results in flu, RSV, and paraflu assays. Affected units include specific box/tray lots listed in the recall notice.
Hologic recalls Selenia Dimensions Mammography System model ASY-04160 with serial numbers 81002143175-81003143247 due to c-arm seizing or dropping during field repairs and cleaning, posing a risk of equipment damage or injury.
Hologic recalls Panther Fusion Extraction Reagent-S (lot 258402) due to potential false positive/negative flu test results. Affected users should contact for remedy.
Hologic recalls I-View Contrast Enhanced Digital Mammography units due to calibration issues affecting contrast visualization in subtracted images. All units are affected.
Hologic recalls Panther Fusion devices with serial numbers 2090002307-2492 due to risk of glass panel falling and hitting operators during use.
Hologic recalls Rapid for TLiIQ System cassettes (catalog 01200Q) due to unapproved material change from a new supplier. No immediate action needed as the hazard is low risk.
Hologic recalls Rapid cassettes (catalog 01200) due to unapproved material from a new supplier. This could pose risks if used without FDA approval. Affected users should check their model numbers.
Hologic recalls Panther System (Catalog 902615) for potential incorrect test results due to an incorrect incubator installation. Affected units have serial number 20900001124.
