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…
Read the official notice →- Date
- 2024-10-23
- Country
- United States
- Brand
- Leica Biosystems Nussloch
- Product
- Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for…
- Classification
- Class II
- Units
- US Nationwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Leica Biosystems Nussloch recalls
- 2025-03-05
USLEICA 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 →- 2024-08-14
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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 → - 2024-06-12
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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 → - 2024-05-01
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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…
Other drugs & medical recalls in the United States
- 2024-10-23
- US
Beckman Coulter, Inc. recalls The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human…
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FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice → - US
Beckman Coulter, Inc. recalls Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with…
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CUE HEALTH INC recalls Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
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Merit Medical Systems, Inc. recalls basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
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FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
Stryker Corporation recalls 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement…
May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus,…
FDA · DeviceStryker CorporationWorldwide distribution - US Nationwide and the countries of Canada, Columbia.Official notice → - US
Merit Medical Systems, Inc. recalls Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe…
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice →