Siemens Healthcare Diagnostics, Inc. Recall 87319
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.
Siemens Healthcare Diagnostics, Inc. Recall 87319 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1188-2021 |
| Event ID | 87319 |
| Event 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. |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 4174 devices (Domestic: 2836 devices, Foreign: 1338 devices) |
| Recall Reason | 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. |
| Device Classification | 20210317 |
| Device Code Info | Product: DV HDLC; Lot #: 20062BA; UDI Number: 0084276802043820062BA21030210464340840 |
| Center Classification Date | 20210308 |
| Recall Initiation Date | 20210203 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
| Similar To |