Z-0894-2022Class II

BenchMark ULTRA and DISCOVERY ULTRA Instruments

Name: Z-0894-2022 BenchMark ULTRA and DISCOVERY ULTRA Instruments
Creator: Ventana Medical Systems Inc
Published: 2022-01-20
License: https://open.fda.gov/license/

Ventana Medical Systems Inc / initiated 2022-01-20 / Open, Classified / root cause: design

FDA source

Ventana Medical Systems Inc began a recall of BenchMark ULTRA and DISCOVERY ULTRA Instruments on 2022-01-20. FDA classified it as Class II and gives the reason as "Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire". 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-0894-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-20
Posted: 2022-04-08
Recalling firm: Ventana Medical Systems Inc
Product: BenchMark ULTRA and DISCOVERY ULTRA Instruments
Product code: KPA Slide Stainer, Automated
Reason for recall: Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.
Root cause tag: design
FDA root cause: Device Design
Action: On 01/20/22, correction notices were sent to customers who were asked to take the following actions needed to continue affected device use: 1) Inform any operators of the potential hazards associated with this issue and provide a copy of this notification as appropriate. 2) Inspect the instrument daily for evidence of leaks (i.e., liquid on the floor, or in and around the instrument). 3) If you experience a fluid leak, stop using the system and turn off the power to the instrument. Immediately contact the firm's Network Customer Support Center at 1-800-227-2155. 4) Complete the attached fax back form and return via fax or email. 5) If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. 6) File this UMDC for future reference. The firm will send a representative to schedule a visit to perform an inspection, reroute cables, and replace parts as necessary to help mitigate the issue. Customers with questions were encouraged to call the Customer Support Center at the before mentioned number; support is available 24 hours a day, seven days a week. On 4/19/23, correction notices were distributed to additional customers who may have received devices without a drip loop, which is the solution to this event. Customers were told they would be contacted by a Service Representative to coordinate specific service actions, including the inspection of GPIO boards and rerouting cables - drip loop introduction.
Quantity in commerce: 9214
Distribution: US: CA, IL, PA, FL, AZ, NY, OH, CO, AR, NC, MD, AL, AK, LA, IA, MN, MA, ND, IN, TX, TN, CT, SC, GA, UT, WI, VA, SD, KY, MS, MO, DE, MI, MT, NJ, WV, OK, WA, OR, PR, DC, NM, ID, NH, NE, ME, KS, HI, NV, RI, WY, VT OUS: Australia, Austria, Belgium, Canada, China, Croatia, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, United Kingdom, Algeria, Argentina, Aruba, Bosnia-Herzegovina., Brazil, Bulgaria, Chile, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Greece, Indonesia, Ireland, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Martinique, Mexico, Monaco, Morocco, Namibia, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Reunion, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, Vietnam, White Russia, Zimbabwe
Product codes and lots: Serial Numbers Less-Than-Or-Equal-To 322030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0894-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0894-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-07

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)