Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the d...
FDA Device Recall #Z-1188-2021 — Class II — February 3, 2021
Recall Summary
| Recall Number | Z-1188-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 3, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Healthcare Diagnostics, Inc. |
| Location | Newark, DE |
| Product Type | Devices |
| Quantity | 4174 devices (Domestic: 2836 devices, Foreign: 1338 devices) |
Product Description
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.
Reason for Recall
Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the countries of Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Portugal, SA, Slovakia, Slovenia, Spain, Switzerland.
Lot / Code Information
Product: DV HDLC; Lot #: 20062BA; UDI Number: 0084276802043820062BA21030210464340840
Other Recalls from Siemens Healthcare Diagnostics, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1484-2026 | Class II | Atellica CH Urine Albumin (UAlb). Material Numb... | Jan 20, 2026 |
| Z-0491-2026 | Class II | IMMULITE 2000 Oak Mix Specific Allergen; Sieme... | Oct 6, 2025 |
| Z-0492-2026 | Class II | 3gAllergy Specific IgE Universal Kit; Kit Comp... | Oct 6, 2025 |
| Z-0493-2026 | Class II | Food Panel 3 Specific Allergen; Siemens Materi... | Oct 6, 2025 |
| Z-0366-2026 | Class II | Assay: IMMULITE 2000 Intact PTH; Test Code: iP... | Sep 22, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.