Dimension Vista HDLC - colorimetric method recall
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes…
Why was Dimension Vista HDLC - colorimetric method recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product: DV HDLC; Lot #: 20062BA; UDI Number: 0084276802043820062BA21030210464340840
- Product
- Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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, Canada, Denmark, France, Germany, Italy, Netherlands, Portugal, SA, Slovakia, Slovenia, Spain, Switzerland.
- Recall date
- March 17, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)