Hologic, Inc recalls Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture…
Failed stability specifications for reagent kits that may result in false negative test results.
Read the official notice →- Date
- 2022-03-23
- Country
- United States
- Brand
- Hologic
- Product
- Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of AR, CA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-04-03
USHologic, 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 →- 2024-01-31
- US
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.
FDA · DeviceHologic, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AR,…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 → - 2022-04-13
- US
Hologic, Inc recalls Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
FDA · DeviceHologic, IncUS: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA,…Official notice →
Other drugs & medical recalls in the United States
- 2022-03-23
- US
Hill-Rom, Inc. recalls (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko…
Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail appropriately and could loosen…
FDA · DeviceHill-Rom, Inc.Worldwide distribution - US Nationwide and the countries of AT, CA, CZ, DE,…Official notice → - US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls LINQ II Insertable Cardiac Monitor
Devices may lose functionality due to susceptibility to moisture ingress.
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Worldwide distribution - US Nationwide distribution in the states of NJ, NY,…Official notice → - US
Boston Scientific Corporation recalls HYDRATOME RX 44-20MM/450CM Material Number: M00583060
Sterility of device is compromised due to a sterile barrier breach
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Abbott Laboratories, Inc recalls Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro…
Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
FDA · DeviceAbbott Laboratories, IncWorldwide distribution: US (nationwide) including states of: AL, CA, GA, IL,…Official notice → - US
Siemens Medical Solutions USA, Inc. recalls Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system…
The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study…
FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide distribution: US (nationwide) and countries of: Algeria, Andorra,…Official notice → - US
SD Biosensor, Inc. recalls STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of…
Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.