CLASS II Device recall · Reported 8 Dec 2021 · FDA Enforcement Report
Dimension Vista-vitro diagnostic device intended recalled
Siemens Healthcare Diagnostics is recalling Dimension Vista-vitro diagnostic device intended to duplicate manual analytical, distributed nationwide in the US. The recall was initiated on 15 Oct 2021 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-0330-2022
- FDA event ID
- 89008
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Oct 2021
- FDA classified
- 2 Dec 2021
- Reported
- 8 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Oct 2021 | Recall initiated by company | |
| 2 Dec 2021 | Classified by FDA | +48 days |
| 8 Dec 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of DE, ES, FR, IT, CA, NL, JP, PT, AU, CZ, AT, DK, SI, BE, SK, QA, SA, KR, CH.
Questions about this recall
Why was it recalled?
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
Which lots are affected?
All software versions prior to 3.10.2. GTIN: 00630414949741 and 00630414945460 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of DE, ES, FR, IT, CA, NL, JP, PT, AU, CZ, AT, DK, SI, BE, SK, QA, SA, KR, CH.
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.
Other products in this recall event
1 other product · FDA event 89008This product is part of a recall event; the main page for the event is Dimension Vista-vitro diagnostic device intended recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dimension Vista-vitro diagnostic device intended recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
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