CLASS I Device recall · Reported 26 Sep 2018 · FDA Enforcement Report
ultraView SISH DNP Detection Kit US recalled by Ventana Medical Systems
Ventana Medical Systems is recalling ultraView SISH DNP Detection Kit US. The recall was initiated on 2 Aug 2018 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2999-2018
- FDA event ID
- 80807
- Recalling firm
- Ventana Medical Systems, Oro Valley, AZ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 2 Aug 2018
- FDA classified
- 14 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Aug 2018 | Recall initiated by company | |
| 14 Sep 2018 | Classified by FDA | +43 days |
| 26 Sep 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
Where it was distributed
worldwide
Questions about this recall
Is ultraView SISH DNP Detection Kit US recalled?
Yes. Ventana Medical Systems recalled ultraView SISH DNP Detection Kit US on 2 Aug 2018. The recall is Class I and its status is Terminated. Recall number Z-2999-2018.
Why was it recalled?
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Which lots are affected?
Lot Number: Y24347, UDI: 4015630970384
Where was it sold?
worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ventana Medical Systems
All 42| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | navify Digital Pathology (on-prem) v2.5 recalled | Ventana Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody recalled | Ventana Medical Systems | Other | Nationwide |
| Device | CLASS II | Ventana Pd-L1 (SP142) Ventana Pd-L1 (SP142) Assay recalled | Ventana Medical Systems | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Ventana HE 600 System, automated slide preparer, for use recalled | Ventana Medical Systems | Packaging Defects | 35 states |
| Device | CLASS II | BenchMark Ultra and Discovery Ultra Instruments recalled | Ventana Medical Systems | Packaging Defects | 52 states |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |