Recall Z-2175-2012 ยท LEH Radioimmunoassay, Vancomycin
Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.
| Date | Aug 9, 2012 (initiated Jul 17, 2012) |
| Status | Terminated |
| Reason | Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System. |
| Root cause | Nonconforming Material/Component |
| Action | The firm initiated their recall of this product on July 17, 2012 by sending an Urgent Field Safety Notification via FedEx next day delivery to all consignees. The Notice informed consignees of the high calibration slopes with the affected device. Affected consignees were requested to immediately discontinue use and discard any remaining Dimension Vista(R) VANC Flex(R) reagent cartridges, lot 12095AD. Affected customers were provided with replacement cartridges. Customers were to also complete the attached form and fax it back to the number provided. The notification letter should be forwa |
| Quantity | 1,894 cartons |
| Distribution | Worldwide Distribution -- US, including Washington, DC and the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WV, and the countries of Canada, New Zealand, Germany, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061655 | DIMENSION VISTA FLEX REAGENT CARTRIDGES Dade Behring, Inc., Jul 10, 2006 |