Drugs & medicalClass II

Binx Health, Inc. recalls binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101

May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative CT or positive CT results

Read the official notice →
Date
2023-05-31
Country
United States
Brand
Binx Health, Inc.
Product
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
Classification
Class II
Units
In the US state of PA
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 Details may be shortened or out of date; the official notice is the authoritative source.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.

Other drugs & medical recalls in the United States

  1. 2023-05-31
  2. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use…

    Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.US Nationwide and Worldwide Distribution Foreign: Argentina Australia…Official notice →
  3. US
    Drugs & medicalClass II

    Arjohuntleigh Magog, Inc. recalls Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting…

    Some Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach.

    FDA · DeviceArjohuntleigh Magog, Inc.US: OH, NYOfficial notice →
  4. US
    Drugs & medicalClass II

    Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c…

    Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis

    FDA · DeviceOrtho-Clinical Diagnostics, Inc.US Nationwide- Worldwide Distribution. Foreign: Australia Belgium Brazil…Official notice →
  5. US
    Drugs & medicalClass II

    PHILIPS HEADQUARTERS CAMBRIDGE recalls Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144

    Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

    FDA · DevicePHILIPS HEADQUARTERS CAMBRIDGEAR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia…Official notice →
  6. US
    Drugs & medicalClass II

    Windstone Medical Packaging, Inc. recalls Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO

    Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

    FDA · DeviceWindstone Medical Packaging, Inc.US: MA OUS: NoneOfficial notice →
  7. US
    Drugs & medicalClass I

    BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25…

    There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.

    FDA · DeviceBERLIN HEART GMBHDistribution to US states of MA, TX, WI, CA, SC, FL, CO, NY, PA, NC, UT, GA,…Official notice →
See all drugs & medical recalls →