Z-0085-2021Class II

BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001

Name: Z-0085-2021 BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
Creator: Roche Diagnostics Operations, Inc.
Published: 2020-08-31
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2020-08-31 / Open, Classified / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001 on 2020-08-31. FDA classified it as Class II and gives the reason as "Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket". 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-0085-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-08-31
Posted: 2020-10-08
Recalling firm: Roche Diagnostics GmbH
Product: BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
Product code: KPA Slide Stainer, Automated
Reason for recall: Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket
Root cause tag: design
FDA root cause: Device Design
Action: Roche issued Urgent Medical Device Correction letter on 8/31/20 via UPS Ground Receipt stating: reason for recall, health risk and action to take: actions below. " Inform any operators that use the BenchMark ULTRA and DISCOVERY ULTRA instruments of the potential hazards associated with this issue and provide a copy of this notification as appropriate. " Inspect the instrument daily for evidence of leaks (i.e., liquid outside of the waste reservoir, liquid on the floor, liquid on the skin/outer panel of the instrument). " If you experience a fluid leak, stop using the system and turn off the power to the instrument. Immediately contact the Roche Support Network Customer Support Center at 1-800-227-2155. " Complete the attached fax back form (TP-01057) and fax or email it according to the instructions on the form. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference Local Field Engineering Specialists (FESs) will perform specific service actions, including the completion of the Waste Tub and Filter Upgrade (if it has not already been implemented), inspection of specific instrument parts for signs of cracks and fluid leaks, and installation of a power connector shield, which will prevent fluid entry into the power cord connection and socket. Contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-227-2155 if you have questions about the information contained in this UMDC.
Quantity in commerce: 2623 (US); 3735 (ex-US)
Distribution: Nationwide Foreign: Canada, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, UK, Algeria, Argentina, Aruba, Australia, Bahrain, Bosnia-Herz., Brazil, Chile, China, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, Egypt, El Salvador, Hong Kong, India, Israel, Japan, Jordan, Kazakhstan, Kuwait, Malaysia, Martinque, Mexico, Monaco, Morocco, Namibia, New Caledonia, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Russia, Saudi Arabia, Singapore, S. Africa, S. Korea, Taiwan, Thailand, Ukraine, UAE, Vietnam
Product codes and lots: All units

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0085-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0085-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-14	2020-10-08
Z-0086-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-14	2020-10-08

Product code KPA

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)