Recall Atlas

Leica Biosystems Nussloch recalls

5 official recalls and safety alerts involving Leica Biosystems Nussloch since 2024-05, 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 Leica Biosystems Nussloch or the relevant agency.

  1. 2025-03-05
  2. US
    Drugs & medicalClass II

    LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01

    Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.

    FDA · DeviceLEICA BIOSYSTEMS NUSSLOCH GMBHWorldwide - US Nationwide distribution in the states of Idaho and Ohio. The…Official notice →
  3. 2024-10-23
  4. US
    Drugs & medicalClass II

    LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2;…

    As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause…

    FDA · DeviceLEICA BIOSYSTEMS NUSSLOCH GMBHUS Nationwide distribution.Official notice →
  5. 2024-08-14
  6. US
    Drugs & medicalClass II

    LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.

    An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.

    FDA · DeviceLEICA BIOSYSTEMS NUSSLOCH GMBHUS Nationwide, including government distribution.Official notice →
  7. 2024-06-12
  8. US
    Drugs & medicalClass II

    LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.

    Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.

    FDA · DeviceLEICA BIOSYSTEMS NUSSLOCH GMBHWorldwide - US Nationwide distribution including in the states of AK, AL, AZ,…Official notice →
  9. 2024-05-01
  10. US
    Drugs & medicalClass II

    LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

    There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or…

    FDA · DeviceLEICA BIOSYSTEMS NUSSLOCH GMBHUS, NationwideOfficial notice →