Drugs & medicalClass II

Biomerieux Inc recalls PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Read the official notice →
Date
2023-01-11
Country
United States
Brand
Biomerieux
Product
PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
Classification
Class II
Units
US Nationwide distribution.
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2025-10-08
  2. US
    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 →
  3. 2024-05-01
  4. US
    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 →
  5. 2023-03-08
  6. US
    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 →
  7. 2022-10-05
  8. US
    Drugs & medicalClass II

    bioMerieux, Inc. recalls VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.

    Invalid calibrations (out of range high) while using the product.

    FDA · DevicebioMerieux, Inc.Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH,…Official notice →
  9. 2022-09-07
  10. US
    Drugs & medicalClass II

    bioMerieux, Inc. recalls VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9

    There are 7 reported software anomalies that may affect use of the device.

    FDA · DevicebioMerieux, Inc.International distribution to the countries of Estonia, Bahrain, Pakistan, UK,…Official notice →
  11. 2022-08-31
  12. US
    Drugs & medicalClass II

    bioMerieux, Inc. recalls NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

    There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.

    FDA · DevicebioMerieux, Inc.Distribution was made to AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN,…Official notice →
All 16 Biomerieux recalls →

Other drugs & medical recalls in the United States

  1. 2023-01-11
  2. US
    Drugs & medicalClass II

    Altimate Medical, Inc. recalls ActiveAid 922, Shower/Commode Chair

    Device manufactured with a component with affects the foldability of the frame, not allowing it to be secured by the frame strap in the folded position.

    FDA · DeviceAltimate Medical, Inc.US Nationwide distribution in the state of Texas.Official notice →
  3. US
    Drugs & medicalClass II

    Detect Headquarters recalls Detect Covid-19 Test Product/Model Number: 21205

    There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring…

    FDA · DeviceDetect HeadquartersDomestic distribution nationwide. Foreign distribution to Hong Kong.Official notice →
  4. US
    Drugs & medicalClass II

    Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone…

    Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results

    FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →
  5. US
    Drugs & medicalClass II

    Beaver Visitec International, Inc. recalls Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part…

    Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection

    FDA · DeviceBeaver Visitec International, Inc.US Nationwide distribution.Official notice →
  6. US
    Drugs & medicalClass II

    Steris Corporation recalls VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of…

    Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others…

    FDA · DeviceSteris CorporationNationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZAOfficial notice →
  7. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.

    Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN…

    FDA · DeviceBeckman Coulter, Inc.US and Canada, Brazil, Korea, Mexico, Puerto Rico, TaiwanOfficial notice →
See all drugs & medical recalls →