LEICA BIOSYSTEMS NUSSLOCH GMBH Recalls

10 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (10)

January 30, 2025
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.
Class II
September 4, 2024
Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples
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
September 4, 2024
Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples
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
September 4, 2024
Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples
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
September 4, 2024
Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples
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
September 4, 2024
Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
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
September 4, 2024
Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
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
May 10, 2024
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.
Class II
April 10, 2024
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.
Class II
November 20, 2023
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 edited protocols.
Class II

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