CLASS II ONGOING Device recall · Reported 5 Jun 2024 · FDA Enforcement Report
Dako CoverStainer, Dako CoverStainer CPO CoverStainer recalled
Agilent Technologies is recalling Dako CoverStainer, Dako CoverStainer CPO CoverStainer, CoverStainer CPO, distributed nationwide in the US. The recall was initiated on 2 Apr 2024 and the FDA has classified it as Class II.
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-1919-2024
- FDA event ID
- 94439
- Recalling firm
- Agilent Technologies, Loveland, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Apr 2024
- FDA classified
- 29 May 2024
- Reported
- 5 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Medical Software
Timeline
| 2 Apr 2024 | Recall initiated by company | |
| 29 May 2024 | Classified by FDA | +57 days |
| 5 Jun 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A
Where it was distributed
Worldwide - US Nationwide distribution in the states of CA, TN, MI, MD, MA, OR, AK, MO, NC, NH, GA, RI and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, Spain, Italy, Japan, Malaysia, Netherland, New Zealand, Norway, Peru, South Korea, Sweden, Switzerland, Taiwan, The United Kingdom, Algeria, Bulgaria, Costa Rica, Cyrpus, Czech Republic, Ecuador, Egypt, Estonia, Greece, Hungary, India, Iraq, Ireland, Isreal, Kenya, Kuwait, Latvia, Lebanon, Morocco, Oman, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovakia, Thailand, Turkey, Ukraine, United Arab Emirates, Vietnam.
Nationwide AlaskaCaliforniaGeorgiaMassachusettsMarylandMichiganMissouriNorth CarolinaNew HampshireOregonRhode IslandTennessee
Questions about this recall
Is Dako CoverStainer, Dako CoverStainer CPO CoverStainer, CoverStainer CPO recalled?
Yes. Agilent Technologies recalled Dako CoverStainer, Dako CoverStainer CPO CoverStainer, CoverStainer CPO on 2 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-1919-2024.
Why was it recalled?
There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
Which lots are affected?
Lot Code: All Lots
Where was it sold?
Worldwide - US Nationwide distribution in the states of CA, TN, MI, MD, MA, OR, AK, MO, NC, NH, GA, RI and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, Spain, Italy, Japan, Malaysia, Netherland, New Zealand, Norway, Peru, South Korea, Sweden, Switzerland, Taiwan, The United Kingdom, Algeria, Bulgaria, Costa Rica, Cyrpus, Czech Republic, Ecuador, Egypt, Estonia, Greece, Hungary, India, Iraq, Ireland, Isreal, Kenya, Kuwait, Latvia, Lebanon, Morocco, Oman, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovakia, Thailand, Turkey, Ukraine, United Arab Emirates, Vietnam.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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