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Lower risk Medical device recall · FDA · Published August 2, 2018

Ventana HPV III Fam 16 Probe Recall: False Negative IHC Results Risk

Ventana recalls HPV III Fam 16 Probe (model 800-4295) due to risk of false negative immunohistochemistry results from leaking reagent dispensers. Affected units sold in US with specific catalog number and lot.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3014-2018Medical deviceVentana ›
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Contact the company

Recalling firmVentana Medical Systems Inc1910 E Innovation Park Dr · Oro Valley, AZ 85755-1962
✎ GovInfoNow plain-language explainer

Ventana is recalling its HPV III Fam 16 Probe (model 800-4295) because leaking reagent dispensers could cause false negative results in immunohistochemistry tests. This might lead to incorrect diagnoses if used in medical testing. Read more at govinfonow.com/recall/70195-ventana-hpv-iii-fam-16-probe-recall-false-negative-ihc.

Source Summary by GovInfoNow · govinfonow.com/recall/70195-ventana-hpv-iii-fam-16-probe-recall-false-negative-ihc · Updated August 20, 2026 · FDA enforcement record: FDA #Z-3014-2018

Cite this page

“Ventana HPV III Fam 16 Probe Recall: False Negative IHC Results Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70195-ventana-hpv-iii-fam-16-probe-recall-false-negative-ihc. Based on FDA recall #Z-3014-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3014-2018%22&limit=1).

The FDA announced on August 2, 2018, that Ventana Medical Systems Inc. is recalling the INFORM HPV III Fam 16 Probe due to leaking and sticking reagent dispensers. These defects may cause false negative immunohistochemistry results.

How to tell if you have it

  • Brand: Ventana
  • Product: INFORM HPV III Fam 16 Probe - US Export
  • Catalog Number: 05278856001
  • Model: 800-4295 Immunohistochemistry (IHC)
  • Lot Number: Y19417
  • UDI: 4015630972210

The hazard

The recall addresses leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. According to the FDA, these issues may result in false negative immunohistochemistry results.

Context

GovInfoNow's records show Ventana Medical Systems, Inc. has had 7 other recalls on record since December 19, 2017. Other recent recalls of similar products include the Ventana navify Digital Pathology v2.5 Software Image Discrepancy Recall (April 20, 2026), the Ventana anti-CD10 antibody recall (June 27, 2024), and the Ventana PD-L1 (SP142) Assay Recall (November 18, 2022). Other recent recalls of similar products include the Hologic Aptima HPV Assay Kit Recall (February 18, 2026), the Diagnostica Stago Asserachrom HPIA Kit Recall (December 15, 2025), and the Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026).

How to tell if you have this one

Check for the model number 800-4295 on the probe. The product was sold in the US with catalog number 05278856001 and lot number Y19417.

  • Brand
    Ventana
  • Category
    Medical device
FDA recall event · 21 products

All 21 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Terminated
  • Distribution
    worldwide
Recall numberProduct, codes & lotsQuantity
Z-2996-2018OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Numbers: Y25760, E00119, Y24225, UDI: 401563098403911,712 units
Z-2997-2018ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Numbers: Y25695, Y22147, UDI: 401563097217314,655 units
Z-2998-2018iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Number: Y24245, UDI: 40156309717493068 units
Z-2999-2018ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Number: Y24347, UDI: 401563097038496 units
Z-3000-2018OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Number: Y26282, UDI: 4015630984749461 units
Z-3001-2018iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.; Lot Number: Y19981, UDI: 401563097026110 units
Z-3002-2018ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Numbers: Y15410, Y24365 UDI: 40156309720292136 units
Z-3003-2018ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Number: Y21610, UDI: 4015630971572354 units
Z-3004-2018ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Numbers: Y15071, Y18053, Y22469, UDI: 40156309722588211 units
Z-3005-2018ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Numbers: Y13927, Y18872, Y22569, Y25883, UDI: 40156309718862231 units
Z-3006-2018CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Numbers: Y12992, Y18852, Y23051, UDI: 40156309722031655 units
Z-3007-2018CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Numbers: Y18586, Y24472, UDI: 40156309722341719 units
Z-3008-2018VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Numbers: Y15105, Y22455, UDI: 4015630971930559 units
Z-3009-2018VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Number: Y20881, UDI: 401563098453475 units
Z-3010-2018VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Numbers: Y12986, Y16448, Y24119, Y16912Z, UDI: 40156309700182753 units
Z-3011-2018CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Number: Y23135, UDI: 4015630970476120 units
Z-3012-2018CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Numbers: Y13547, Y19158, UDI: 4015630970469468 units
Z-3013-2018CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Numbers: Y16507, Y23040, UDI: 4015630984398240 units
Z-3014-2018INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Number: Y19417, UDI: 4015630972210195 units
Z-3015-2018NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Numbers: Y22285, Y25750. UDI: 40156309702542172 units
Z-3016-2018ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IHC) for in vitro diagnostic use.; Lot Number: Y26299, UDI: 4015630972500342 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the model number 800-4295 and catalog number 05278856001 on the probe.

How this recall unfolded

Recall timeline

FDA terminated this recall 3.3 years after the firm started it.

1. Firm started the recall: Aug 2, 201812. FDA classified it Class I: Sep 14, 201823. Published in FDA’s Enforcement Report: Sep 26, 201834. FDA terminated the recall: Nov 22, 2021420182021
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this product dangerous?

The recall is for potential false negative results in immunohistochemistry tests, not immediate physical danger.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3014-2018 (August 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3014-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA