Recall Z-1188-2021 ยท JHM Colorimetric Method, Lipoproteins
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Feb 3, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Correction (UMDC # VC-21-01.A.US) and Urgent Field Safety Notice (UFSN # VC-21-01.A.OUS) were issued on January 26, 2021 to all Dimension Vista customers who received the Dimension Vista HDLC flex reagent lot 20062BA to notify them of the issue, the potential risk to health, and actions to be taken by the customer. |
| Quantity | 4174 devices (Domestic: 2836 devices, Foreign: 1338 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081300 | DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE Siemens Healthcare Diagnostics, Jul 2, 2008 |