CLASS II ONGOING Device recall · Reported 20 Jul 2022 · FDA Enforcement Report
Ventana HE 600 System, automated slide preparer, for use recalled
Ventana Medical Systems is recalling Ventana HE 600 System, automated slide preparer, for use in laboratories, distributed in 35 states. The recall was initiated on 1 Jun 2022 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-1374-2022
- FDA event ID
- 90363
- Recalling firm
- Ventana Medical Systems, Oro Valley, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Jun 2022
- FDA classified
- 12 Jul 2022
- Reported
- 20 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 1 Jun 2022 | Recall initiated by company | |
| 12 Jul 2022 | Classified by FDA | +41 days |
| 20 Jul 2022 | Published in enforcement report | +8 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 a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
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
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Where it was distributed
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, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, UK, Argentina, Australia, Brazil, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Israel, Japan, Kuwait, Lebanon, Malaysia, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates (UAE), Vietnam
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIllinoisKansasKentuckyMassachusettsMarylandMichiganMinnesotaMissouriMississippiMontana
Questions about this recall
Why was it recalled?
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
Which lots are affected?
All Lots; UDI/DI: 04015630976010
Where was it sold?
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, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, UK, Argentina, Australia, Brazil, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Israel, Japan, Kuwait, Lebanon, Malaysia, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates (UAE), 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 26 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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