Z-1947-2024Class II

Leica HistoCore PEGASUS Tissue Processor, REF 14048858005

Name: Z-1947-2024 Leica HistoCore PEGASUS Tissue Processor, REF 14048858005
Creator: Leica Biosystems Nussloch Gmbh
Published: 2024-04-10
License: https://open.fda.gov/license/

Leica Biosystems Nussloch GmbH / initiated 2024-04-10 / Open, Classified / root cause: design

FDA source

LEICA BIOSYSTEMS NUSSLOCH GMBH began a recall of Leica HistoCore PEGASUS Tissue Processor, REF 14048858005 on 2024-04-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1947-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-10
Posted: 2024-06-04
Recalling firm: Leica Biosystems Nussloch GmbH
Product: Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Product code: IEO Processor, Tissue, Automated
Reason for recall: 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 tag: design
FDA 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 in commerce: 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.
Product codes and lots: All devices with serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782; UDI-DI 04049188216397.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1947-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1947-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-06-04

Product code IEO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)