Recall Z-1622-2016 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Feb 16, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens Healthcare sent an Urgent Medical Device Correction letter dated February 2016, to all affected customers. It was determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15299BB, 15300BA, 15320BB and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagent cartridges manufacture from specific mold/cavity identifies as described in Table 2 of the Urgent Medical Device Correction notification sent to customers. Please retain this letter with your laboratory records, and forward this letter to those who |
| Quantity | 18668 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM Dade Behring, Inc., Jul 11, 2005 |