Recall Atlas

Helena Laboratories recalls

2 official recalls and safety alerts involving Helena Laboratories since 2022-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Helena Laboratories or the relevant agency.

  1. 2023-06-28
  2. US
    Drugs & medicalClass II

    Helena Laboratories, Corp. recalls Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in…

    Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no…

    FDA · DeviceHelena Laboratories, Corp.Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to…Official notice →
  3. 2022-06-15
  4. US
    Drugs & medicalClass II

    Helena Laboratories, Corp. recalls V8 Immunodisplacement Kit REF 1803

    Due to microbial growth causing interference with interpretation.

    FDA · DeviceHelena Laboratories, Corp.U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,Official notice →