Drugs & medicalClass II

Qiagen GmbH recalls QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the…

If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be…

Read the official notice →
Date
2023-08-02
Country
United States
Brand
Qiagen
Product
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the…
Classification
Class II
Units
AL, AR, CA, DC, FL, GA, ID, KS, KY, MD, MN, NJ, NY,PA, SC, TX, VA
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Qiagen recalls

  1. 2023-10-11
  2. US
    Drugs & medicalClass II

    Qiagen GmbH recalls therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic…

    Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be…

    FDA · DeviceQiagen GmbHWorldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN,…Official notice →
  3. 2023-08-02
  4. US
    Drugs & medicalClass II

    Qiagen GmbH recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients…

    Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated

    FDA · DeviceQiagen GmbHDC, AL, CA, FL, GA, ME, NC, NY, OR, TX Foreign: DE, AE, AT, BE, BG, CH, CL,…Official notice →
All 3 Qiagen recalls →

Other drugs & medical recalls in the United States

  1. 2023-08-02
  2. US
    Drugs & medicalClass II

    Medtronic Neuromodulation recalls A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..

    When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not…

    FDA · DeviceMedtronic NeuromodulationInternational distribution to the countries of Israel and Serbia.Official notice →
  3. US
    Drugs & medicalClass III

    Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the…

    May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).

    FDA · DeviceOrtho-Clinical Diagnostics, Inc.US Nationwide distribution in the state of CA.Official notice →
  4. US
    Drugs & medicalClass II

    Datascope Corp. recalls LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product…

    During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending…

    FDA · DeviceDatascope Corp.Domestic distribution nationwide. International distribution worldwide.Official notice →
  5. US
    Drugs & medicalClass I

    Hamilton Medical, Inc. recalls HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally…

    Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.

    FDA · DeviceHamilton Medical, Inc.U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware…Official notice →
  6. US
  7. US
    Drugs & medicalClass II

    New Vitalis Pharmacy LLC dba New Vitalis Pharmacy recalls Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For…

    Lack of Assurance of Sterility

    FDA · DrugNew Vitalis Pharmacy LLC dba New Vitalis PharmacyNationwideOfficial notice →
See all drugs & medical recalls →