FDA Medical Device Recalls (openFDA)
LEICA BIOSYSTEMS NUSSLOCH GMBH: Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
- Recall number
- Z-1947-2024
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Product
- Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
- Status
- Open, Classified
- Initiated
- 2024-04-10
- Posted
- 2024-06-04
- Terminated
- not on file
- 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.
- Root cause
- Device Design
- Action
- 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
- Quantity
- 141 devices
- 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.
- Lot, serial or model codes
- All devices with serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782; UDI-DI 04049188216397.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IEO
- Firm FEI
- 3002179321
- Firm city
- Nussloch
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28