Recall Atlas
Drugs & medicalClass II

BioMerieux SA recalls EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated

Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater timeout after updating to recent firmware SP4 Patch 2

Read the official notice →
Date
2026-11-04
Country
United States
Brand
Biomerieux
Product
EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated
Classification
Class II
Units
Worldwide - US Nationwide distribution in the states of CA, IN, KS, LA, MN,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Biomerieux recalls

  1. 2026-09-30
  2. Drugs & medicalClass II

    Biomerieux Inc recalls VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811

    The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False…

    FDA · DeviceBiomerieux IncInternational distribution to the countries of Austria, Germany, Luxembourg.Official notice →
  3. 2026-07-15
  4. Drugs & medicalClass II

    Biomerieux Inc recalls VITEK 2 AST-N447 TEST KIT Product reference 424620

    Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.

    FDA · DeviceBiomerieux IncInternational distribution to the countries of Belgium and the Netherlands.Official notice →
  5. 2026-02-11
  6. Drugs & medicalClass II

    Biomerieux Inc recalls VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam…

    Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic…

    FDA · DeviceBiomerieux IncWorldwide - US Nationwide distribution.Official notice →
  7. 2025-10-08
  8. Drugs & medicalClass II

    bioMerieux, Inc. recalls VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of…

    Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards

    FDA · DevicebioMerieux, Inc.International distribution in the countries of Albania, Armenia, Australia,…Official notice →
  9. 2024-05-01
  10. Drugs & medicalClass I

    Biomerieux Inc recalls VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF…

    Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result…

    FDA · DeviceBiomerieux IncWorldwideOfficial notice →
  11. 2023-03-08
  12. Drugs & medicalClass II

    Biomerieux Inc recalls MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and…

    For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the…

    FDA · DeviceBiomerieux IncUS Nationwide distribution to the states of Alabama, California, North…Official notice →
All 17 Biomerieux recalls →

Other drugs & medical recalls in the United States

  1. 2026-11-04
  2. Drugs & medicalClass II

    Boston Scientific Neuromodulation Corporation recalls Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu…

    Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue that causes the TD to attempt to restart, then fail, leading…

    FDA · DeviceBoston Scientific Neuromodulation CorporationUS Nationwide distribution in the states of PA, FL, OR, AZ, OH, SC, TX, OR,…Official notice →
  3. Drugs & medicalClass II

    Pentax of America Inc recalls PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.

    Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.

    FDA · DevicePentax of America IncWorldwide - US Nationwide and International distribution - Pending.Official notice →
  4. Drugs & medicalClass II

    Medtronic, Inc. recalls CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable

    Software problem has the potential for an inaccurate displayed longevity estimate.

    FDA · DeviceMedtronic, Inc.Worldwide distribution.Official notice →
  5. Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 5 M12. Model Number: 722227.

    Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice →
  6. Drugs & medicalClass II

    Canon Medical System, USA, INC. recalls ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F

    Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.

    FDA · DeviceCanon Medical System, USA, INC.US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL,…Official notice →
  7. Drugs & medicalClass II

    Philips North America recalls Model Number: 712010.

    Potential for the device to fail immediately after an exposure, causing the system to remain stationary.

    FDA · DevicePhilips North AmericaWorldwide Distribution: (US Nationwide) and International distribution to…Official notice →
See all drugs & medical recalls →