LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany Leica HistoCore PEGASUS Tissue Processor, REF 14048858005. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Brand
LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany
Lot Codes / Batch Numbers
All devices with serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782, UDI-DI 04049188216397.
Products Sold
All devices with serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782; UDI-DI 04049188216397.
LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany is recalling Leica HistoCore PEGASUS Tissue Processor, REF 14048858005. due to Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The recalling firm issued letters to the Canadian consignees on 4/10/2024 via email and to the U.S. consignees on 4/18/2024 via email. The letter explained the reason for recall, the impact of the issue, and advice on immediate actions to be taken. The actions were: (1) Check reagent status in reagent bottles and paraffin status in paraffin bath. In case of any signs of contamination (such as muddiness, turbidity, or liquid separation) are observed, you should stop using the instrument for tissue processing and call for service. When no cross-contamination is observed, continue with the following: (a) In order to ensure defined condition, please check reagent/paraffin level. If they are over the maximum level mark, you should pour out the excess reagent/paraffin, and empty the condensation bottle; (b) To secure further processing, reagent and wax bath levels shall be always checked in terms of not exceeding maximum fill level. As long as maximum fill level is between the minimum and maximum level, your instrument is fine, and you can continue processing. (2) Before running the protocol, inspect the reagent level in reagent bottles and paraffin level in paraffin baths. Make sure that all processing reagents and paraffin level is between the Min and Max. and regularly empty the condensation bottle (weekly). (Refer to IFU 2.2.3 Operating the instrument; 9.3 Cleaning and maintenance schedule). (3) The reagent bottle and paraffin bath should be filled between the Min and Max line as indicated in the Instructions for Use. (Reagent level: Refer to IFU 4.4 Basic instrument/hardware 4.4.1 Retorts). (4) Formalin should be dripped out from the basket before adding it into the retort to avoid large carryover volume of formalin into the reagent bottle. (5) Please check if the current carrier material has large volume of carryover. If yes, please change to an appropriate carrier material. (6) Please do not clean the Mold or metal lid in the retort during the cleaning p
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026