CLASS II ONGOING Device recall · Reported 26 Oct 2022 · FDA Enforcement Report
Dimension Vista High Density Lipoprotein Cholesterol recalled
Siemens Healthcare Diagnostics is recalling Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD, distributed nationwide in the US. The recall was initiated on 24 Aug 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-0089-2023
- FDA event ID
- 90872
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Aug 2022
- FDA classified
- 14 Oct 2022
- Reported
- 26 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 24 Aug 2022 | Recall initiated by company | |
| 14 Oct 2022 | Classified by FDA | +51 days |
| 26 Oct 2022 | 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
Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.
Product as listed by the FDA
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
Where it was distributed
Nationwide Foreign: Canada
Questions about this recall
Why was it recalled?
Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.
Which lots are affected?
UDI-DI : 0084276802043821250BA2022090710464340840 Lot Number: 21250BA Exp. Date: 2022-09-07
Where was it sold?
Nationwide Foreign: Canada
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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