Recall Z-2436-2018 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics, Inc.
Dimension Vista CTNI Sample Diluent, KD692, SMN# 10445205
| Date | Mar 21, 2018 |
| Status | Terminated |
| Reason | The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial. |
| Root cause | Under Investigation by firm |
| Action | Notification letters were distributed 3/21/18. The letters instructed customers to: Inspect stock, discontinue use of and discard the Dimension Vista Diluent lots listed in Table 1. Please review this letter with your Medical Director. Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the produc |
| Quantity | 1446 |
| Distribution | The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081643 | DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 Siemens Healthcare Diagnostics, Jul 3, 2008 |