LEICA BIOSYSTEMS NUSSLOCH GMBH: Device Recall

Recall Details

Recall Number

Z-2529-2024

Classification

Class II

Product Type

Device

Recalling Firm

LEICA BIOSYSTEMS NUSSLOCH GMBH

Status

Ongoing

Date Initiated

05/10/2024

Location

Nussloch, Germany

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

180 devices

Reason for Recall

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.

Product Description

Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.

Distribution Pattern

US Nationwide, including government distribution.

Other Recalls by LEICA BIOSYSTEMS NUSSLOCH GMBH

• Class II: Risk 01/30/2025
  Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
• Class II: Risk 09/04/2024
  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 serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.
• Class II: Risk 09/04/2024
  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 serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.
• Class II: Risk 09/04/2024
  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 serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.
• Class II: Risk 09/04/2024
  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 serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.

View all recalls by LEICA BIOSYSTEMS NUSSLOCH GMBH →