Dimension Vista High Density Lipoprotein Cholesterol — Class II medical device recall Z-0089-2023
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2022-10-26, distributed nationwide. Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or
| Recall number | Z-0089-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2022-08-24 |
| Classified | 2022-10-14 |
| Reported by FDA | 2022-10-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,592 units |
| Lot numbers | 21250BA |
| Model numbers | K3048A |
| Expiration dates | 2022-09-07 |
Product
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0089-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.