CLASS I Device recall · Reported 26 Sep 2018 · FDA Enforcement Report
Confirm anti-Estrogen Receptor (ER) recalled by Ventana Medical Systems
Ventana Medical Systems is recalling Confirm anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody. 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-3007-2018
- 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
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.
Where it was distributed
worldwide
Questions about this recall
Is Confirm anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody recalled?
Yes. Ventana Medical Systems recalled Confirm anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody on 2 Aug 2018. The recall is Class I and its status is Terminated. Recall number Z-3007-2018.
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 Numbers: Y18586, Y24472, UDI: 4015630972234
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.
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