Z-2779-2015Class III

The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S...

Name: Z-2779-2015 The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S...
Creator: Leica Microsystems, Inc.
Published: 2015-08-05
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2015-08-05 / Terminated / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to... on 2015-08-05. FDA classified it as Class III and gives the reason as "The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2779-2015
Classification: Class III
Status: Terminated
Initiated: 2015-08-05
Posted: 2015-09-17
Terminated: 2017-01-05
Recalling firm: Leica Microsystems, Inc.
Product: The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
Product code: IEO Processor, Tissue, Automated
Reason for recall: The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Leica Biosystems sent an Urgent Medical Device Recall Notification letter dated August 4, 2015, to all affected customers to provide instructions on what the customer should do with the recalled product. These include 1) As an immediate countermeasure, the firm recommends that the customers do not use the remote alarm function on the Leica ASP200S/ASP300S in its current state. 2) The customers local Leica representative will contact them to arrange for a Leica service engineer to visit their facility to correct the internal wiring on their tissue processor and to check the remote alarm function. 3) The Medical Device Recall Notification needs to be passed on to all those who need to be aware within the custromers organisation or to any organisation where the potentially affected devices have been transferred. Please maintain awareness of this Medical Device Recall Notification and resulting action to ensure effectiveness of the corrective action. 4) The letter asks the customer use the enclosed Medical Device Recall Notification Response Form to confirm that they have received and understand the Medical Device Recall Notification. it states "Please confirm receipt of this notice by signing and dating the attached Acknowledgement Form and faxing it back to us at 1-847-236-3747, or scan and email it to [email protected]"
Quantity in commerce: 901
Distribution: Worldwide Distribution - US including U.S. including AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, TX, VA, WA, WI, WV and District of Columbia. Internationall to AE, AT, AU , BD , BE, BF, BG,BR, CA, CL, CN, CO, CR, DE, DK, EC, EG, ES, ET, FI, FR, GB, HU, ID, IN, IT, JM, JP, KR, LK, MA, MT, MY, NL, NZ, PA, PE, PH, PL, PT, RO, RU, SA, SE, SG, TH, TR, TW, VN and ZA.
Product codes and lots: Product Code: Leica ASP200S/ASP300S with Serial Numbers: 5682; 5886; 5264; 5267; 5356; 5259; 5956; 5946; 5794; 5385; 5929; 5301; 5401; 5310; 5530; 5909; 5804; 5272; 5724; 5796; 5807; 5446; 5435; 5670; 5947; 5348; 5434; 5388; 5366; 6000; 6131; 5407; 6040; 5799; 5815; 5737; 5706; 5381; 5416; 5673; 5875; 5962; 6041; 6042; 5266; 5948; 5693; 6021; 5610; 5798; 5926; 5387; 5349; 5273; 6115; 5612; 5965; 5955; 5260; 5725; 5871; 5873; 5874; 5562; 6046; 5386; 5977 ;5889; 5398; 6062; 5609; 6015; 5734; 5403; 5289; 5426; 6149; 5663; 6045

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2779-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2779-2015	Class III	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-17

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)