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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge

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  Class 2 Device Recall Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge see related information
Date Initiated by Firm February 03, 2021
Create Date March 08, 2021
Recall Status1 Open3, Classified
Recall Number Z-1188-2021
Recall Event ID 87319
510(K)Number K081300  
Product Classification Colorimetric method, lipoproteins - Product Code JHM
Product 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.
Code Information Product: DV HDLC; Lot #: 20062BA; UDI Number: 0084276802043820062BA21030210464340840 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr
Newark DE 19702-2466
For Additional Information Contact Heydi Calderon
302-689-9814
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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, Canada, Denmark, France, Germany, Italy, Netherlands, Portugal, SA, Slovakia, Slovenia, Spain, Switzerland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JHM and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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