Drugs & medicalClass II

Helena Laboratories, Corp. recalls V8 Immunodisplacement Kit REF 1803

Due to microbial growth causing interference with interpretation.

Read the official notice →
Date
2022-06-15
Country
United States
Brand
Helena Laboratories
Product
V8 Immunodisplacement Kit REF 1803
Classification
Class II
Units
U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Helena Laboratories recalls

  1. 2023-06-28
  2. US
    Drugs & medicalClass II

    Helena Laboratories, Corp. recalls Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in…

    Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no…

    FDA · DeviceHelena Laboratories, Corp.Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to…Official notice →
All 2 Helena Laboratories recalls →

Other drugs & medical recalls in the United States

  1. 2022-06-15
  2. US
    Drugs & medicalClass II

    Getinge Usa Sales Inc recalls Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying…

    Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a…

    FDA · DeviceGetinge Usa Sales IncUS Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.Official notice →
  3. US
    Drugs & medicalClass II

    Medacta Usa Inc recalls GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

    A Size 2 trial baseplate was assembled with Size 1 instrument sets.

    FDA · DeviceMedacta Usa IncDistribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no…Official notice →
  4. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures…

    if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts…

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution.Official notice →
  5. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502…

    Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and…

    FDA · DeviceSiemens Medical Solutions USA, IncDomestic distribution nationwide.Official notice →
  6. US
    Drugs & medicalClass II

    Cook Incorporated recalls Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338…

    The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

    FDA · DeviceCook IncorporatedDomestic distribution nationwide. Foreign distribution worldwide.Official notice →
  7. US
    Drugs & medicalClass II

    Oakworks Inc recalls Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS

    The warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.

    FDA · DeviceOakworks IncUS Nationwide distribution in the states of MA, NJ, and PA.Official notice →
See all drugs & medical recalls →