Drugs & medicalClass II

Phadia US Inc recalls Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or…

Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument

Read the official notice →
Date
2023-07-05
Country
United States
Brand
Phadia US Inc
Product
Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or…
Classification
Class II
Units
US: CA, NJ, MI
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2023-07-05
  2. US
    Drugs & medicalClass II

    Appliedvr recalls RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.

    There is the potential for the program software to malfunction which will not allow it to move forward to the next session.

    FDA · DeviceAppliedvrUS: NY OUS: NoneOfficial notice →
  3. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

    Reagent lot numbers include an insufficient concentration of blocking reagent.

    FDA · DeviceBeckman Coulter, Inc.Distribution was made to CA, CO, CT, FL, GA, IL, IN, MA, MI, NC, NE, NJ, NY,…Official notice →
  4. US
    Drugs & medicalClass II

    Philips North America Llc recalls DigitalDiagnost C90, Model No. 712034 and 712035

    There is a software login in issue that may prevent the user from logging in.

    FDA · DevicePhilips North America LlcDistribution in US: AZ, GA, IN, IA, MN, NE, NH, OH, TX OUS distribution to…Official notice →
  5. US
    Drugs & medicalClass II

    RaySearch America Inc recalls Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1,…

    A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose…

    FDA · DeviceRaySearch America IncUS: AZ, CA, GA & WAOfficial notice →
  6. US
    Drugs & medicalClass II

    Remel, Inc recalls Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In…

    The test medium may not perform as intended.

    FDA · DeviceRemel, IncDistribution was made nationwide, including Puerto Rico. There was no foreign…Official notice →
  7. US
    Drugs & medicalClass II

    Implant Direct Sybron Manufacturing LLC recalls LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW…

    Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

    FDA · DeviceImplant Direct Sybron Manufacturing LLCUS Nationwide distribution in the states of FL, ID, TX, CA.Official notice →
See all drugs & medical recalls →