Recall Z-1622-2016
Siemens Healthcare Diagnostics, Inc. · initiated February 16, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Device Listing # D011374, Lot # 15341AC, 15320BB, 15300BA, 15299BB, 15264BA, 15243BB and 15215AE
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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 may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (302) 631-0528.
Details
- Recall number
- Z-1622-2016
- Initiated
- February 16, 2016
- Terminated
- December 1, 2017
- Product code
- CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen
- 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 the countries of : Canada, United Arab Emir, Australia, Austria, Belgium, Switzerland, Bahamas…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE