Recall Atlas

Haemonetics recalls

2 official recalls and safety alerts involving Haemonetics since 2022-07, 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 Haemonetics or the relevant agency.

  1. 2022-07-06
  2. US
    Drugs & medicalClass II

    Haemonetics Corporation recalls TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

    Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference…

    FDA · DeviceHaemonetics CorporationDomestic distribution US Nationwide.Official notice →
  3. US
    Drugs & medicalClass II

    Haemonetics Corporation recalls Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay -…

    When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion…

    FDA · DeviceHaemonetics CorporationUS Nationwide.Official notice →