Drugs & medicalClass II

Biofire Defense recalls FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative,…

Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.

Read the official notice →
Date
2026-08-12
Country
United States
Brand
Biofire Defense
Product
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative,…
Classification
Class II
Units
U.S. Nationwide distribution in the states of AL, CA, DC, FL, GA, HI, KY, LA,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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 Biofire Defense recalls

  1. 2025-10-01
  2. US
    Drugs & medicalClass II

    Biofire Defense recalls FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use…

    FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.

    FDA · DeviceBiofire DefenseUS Nationwide distribution in the states of AL, AZ, UT, CA, TX, DC , VA, FL,…Official notice →
All 2 Biofire Defense recalls →

Other drugs & medical recalls in the United States

  1. 2026-08-12
  2. US
    Drugs & medicalClass III

    Siemens Healthcare Diagnostics, Inc. recalls Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

    Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is…

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of CA and VA. The country…Official notice →
  3. US
    Drugs & medicalClass I

    Boston Scientific Neuromodulation Corporation recalls INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model:…

    Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention,…

    FDA · DeviceBoston Scientific Neuromodulation CorporationUS: NY. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain,…Official notice →
  4. US
    Drugs & medicalClass II

    GE Medical Systems Information Technologies Inc recalls GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system

    A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information…

    FDA · DeviceGE Medical Systems Information Technologies IncWorldwide - US Nationwide distribution in the state of MI, and the countries…Official notice →
  5. US
    Drugs & medicalClass II

    GE Medical Systems Information Technologies Inc recalls GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph

    Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a…

    FDA · DeviceGE Medical Systems Information Technologies IncWorldwide distribution - US Nationwide and the countries of Belgium, Hong…Official notice →
  6. US
    Drugs & medicalClass II

    Merge Healthcare, Inc. recalls Merge PACS, medical imaging diagnostic workstation

    Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

    FDA · DeviceMerge Healthcare, Inc.Worldwide distribution - US Nationwide and the countries of Canada, and UK.Official notice →
  7. US
    Drugs & medicalClass II

    Biomet, Inc. recalls Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm

    Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

    FDA · DeviceBiomet, Inc.Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA…Official notice →
See all drugs & medical recalls →