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Ventana Medical Systems Inc recall records

5 reported ongoing

5 records in this archive. Latest source date Apr 20, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United...

Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window

Class IIReported ongoing

Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, PR, SC...

Official source
FDA device enforcement

Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND,...

Official source
FDA device enforcement

VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE...

Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead t...

Class IIReported ongoing

Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO,CT, DC, DE, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, ND, NE, NJ, NM, NV, NY, O...

Official source
FDA device enforcement

Ventana HE 600 System, automated slide preparer, for use in laboratories.

There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire

Class IIReported ongoing

Distribution: US: AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD MI MN MO MS MT NC NE NJ NY OH OK OR PA PR SC SD TN TX UT VA WA WI WV OUS: Canada, Austria, Belgium, Croatia, Denmark, Finl...

Official source
FDA device enforcement

BenchMark ULTRA and DISCOVERY ULTRA Instruments

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.

Class IIReported ongoing

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, N...

Official source

Reasons in these listed records

  • Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
  • Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
  • Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative P...
  • There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire

These examples come from this result page and are not a ranking of every recall reason.

Checking Ventana Medical Systems Inc

Is there a recall on ventana medical systems inc right now?

This archive contains 5 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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