Nussloch, Germany
LEICA BIOSYSTEMS NUSSLOCH GMBH recalls
5 recalls recorded since 2018, most recently on 30 January 2025. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)5
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 30 January 2025
- Reason
- Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
- Distribution
- Worldwide - US Nationwide distribution in the states of Idaho and Ohio. The countries of France, Australia, Belgium, China, Germany, Spain, UK, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1247-2025
- Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Ongoing Class II Medical devices
- Recall started
- 4 September 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0088-2025, Z-0085-2025, Z-0087-2025, Z-0090-2025, Z-0086-2025, Z-0089-2025
- Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples
- Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
- Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples
- Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples
- Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
- Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples
Ongoing Class II Medical devices
- Recall started
- 10 May 2024
- Reason
- 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.
- Distribution
- US Nationwide, including government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2529-2024
- Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Ongoing Class II Medical devices
- Recall started
- 10 April 2024
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NV, NY, OH, TN, TX, UT, VA, WA, and WI. There was also government distribution but no military distribution. The country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1947-2024
- Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Ongoing Class II Medical devices
- Recall started
- 20 November 2023
- Reason
- 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.
- Distribution
- US, Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0590-2024
- Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.