Drugs & medicalClass II

Luminex Corporation recalls ARIES HSV 1&2 Assay, Part Number/REF 50-10017

Impacted lot may leak inside the ARIES instrument.

Read the official notice →
Date
2022-01-26
Country
United States
Brand
Luminex
Product
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Classification
Class II
Units
Worldwide distribution - US Nationwide distribution in the states of Alabama,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Luminex recalls

  1. 2022-08-24
  2. US
    Drugs & medicalClass II

    Luminex Corporation recalls ARIES SARS-CoV-2 Assay

    SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative…

    FDA · DeviceLuminex CorporationU.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.Official notice →
  3. 2022-07-13
  4. US
    Drugs & medicalClass II

    Luminex Corporation recalls VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23

    There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.

    FDA · DeviceLuminex CorporationWorldwide distribution - US Nationwide and the countries of Kuwait, Austria,…Official notice →
  5. 2022-05-25
  6. US
    Drugs & medicalClass II

    Luminex Corporation recalls VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

    Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.

    FDA · DeviceLuminex CorporationUSOfficial notice →
  7. US
    Drugs & medicalClass II

    Luminex Corporation recalls Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

    Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

    FDA · DeviceLuminex CorporationUS:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: NoneOfficial notice →
  8. 2022-04-20
  9. US
    Drugs & medicalClass II

    Luminex Corporation recalls Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R

    Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.

    FDA · DeviceLuminex CorporationUS: TX, CT, LAOfficial notice →
  10. 2022-02-09
  11. US
    Drugs & medicalClass II

    Luminex Corporation recalls ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

    Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.

    FDA · DeviceLuminex CorporationWorldwide distribution - US Nationwide distribution in the states of New…Official notice →
All 13 Luminex recalls →

Other drugs & medical recalls in the United States

  1. 2022-01-26
  2. US
    Drugs & medicalClass II

    Draeger Medical, Inc. recalls Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300

    26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas…

    FDA · DeviceDraeger Medical, Inc.US Nationwide distribution in the states of NY, PA, and WI.Official notice →
  3. US
    Drugs & medicalClass II

    Konica Minolta Healthcare Americas, Inc. recalls ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on…

    lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed

    FDA · DeviceKonica Minolta Healthcare Americas, Inc.US Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis…

    Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain…

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of AK, AL, AR, AZ, CA, FL, GU, HI,…Official notice →
  5. US
    Drugs & medicalClass II

    Stanley Security Solutions Inc recalls Senior Living Arial Emergency and Nurse Call Systems

    Systems are not alarming due to increased memory consumption.

    FDA · DeviceStanley Security Solutions IncWorldwide distribution - US Nationwide distribution in the states of FL, MD,…Official notice →
  6. US
    Drugs & medicalClass I

    ev3 Inc. recalls Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014"…

    Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.

    FDA · Deviceev3 Inc.Worldwide Distribution: US (nationwide), including PR; and Foreign…Official notice →
  7. US
    Drugs & medicalClass I

    Mylan Pharmaceuticals Inc recalls Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled…

    Labeling: Missing Label: label missing from some Semglee prefilled pens.

    FDA · DrugMylan Pharmaceuticals IncNationwide in the USA and Thailand.Official notice →
See all drugs & medical recalls →