Hologic, Inc. recalls PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps…
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
Read the official notice →- Date
- 2024-01-31
- Country
- United States
- Brand
- Hologic
- Product
- PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AK, AR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Hologic recalls
- 2024-07-24
US
Hologic Inc recalls Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN,…
Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the…
FDA · DeviceHologic IncWorldwide distribution - US Nationwide and the countries of India, Australia,…Official notice →- 2024-05-15
US
Hologic, Inc recalls BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x…
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the…
- 2024-04-03
US
Hologic, Inc. recalls Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter…
Use of assay along with plasma specimen may result in error code which would invalidate sample.
FDA · DeviceHologic, Inc.Worldwide - US Nationwide distribution in the states of CA, CT, FL, ID, IL,…Official notice →- 2023-07-05
US
Hologic, Inc recalls Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
- 2023-03-01
US
Hologic, Inc. recalls Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D…
C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
- 2022-10-12
US
Hologic, Inc recalls The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is…
Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is…
FDA · DeviceHologic, IncUS Nationwide distribution including in the states of FL, IL, MD, NJ, AZ, TX,…Official notice →
Other drugs & medical recalls in the United States
- 2024-01-31
US
Ossur H / F recalls Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may…
FDA · DeviceOssur H / FUS Nationwide distribution including in the states of MA, SC, MD, TN, ND, VA,…Official notice →US
Beckman Coulter, Inc. recalls Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
FDA · DeviceBeckman Coulter, Inc.US and Australia, Brazil, Canada, China, France, Germany, Ghana, India,…Official notice →US
Phadia Ab recalls EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
US
SEDECAL SA recalls Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take…
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
FDA · DeviceSEDECAL SADistribution was made to AL, FL, and NC. There was no military/government…Official notice →US
Medtronic Neuromodulation recalls Model A710 Intellis Clinician Programmer Application, version 2.0.97
Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability…
US
Medtronic Inc. recalls Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the…