FDAFDA · Food and drugs·Recall number Z-1622-2016
Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.
Published May 18, 2016 · Recall initiated: February 16, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagen cartridges manufactured from specific mold cavities.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide distribution - US (nationwide) distribution including Puerto Rico and to the states of : 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, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. , and to the countries of : Canada, United Arab Emir, Australia, Austria, Belgium, Switzerland, Bahamas, Czech Republic, Germany, Denmark, Spain, Finland, France, Italy, Netherland, Norway, Portugal, Slovakia, Slovenia, Japan, Republic of Korea, New Zealand.
- Lot
- Device Listing # D011374, Lot # 15341AC, 15320BB, 15300BA, 15299BB, 15264BA, 15243BB and 15215AE
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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