Recall Z-1301-2019 ยท JGS Electrode, Ion Specific, Sodium
Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Prime, Material Number 11069001
| Date | Mar 7, 2019 |
| Status | Terminated |
| Reason | There were multiple issues identified in the system software which required an update. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Correction notification letters dated 3/7/19 were sent to customers. |
| Quantity | 474 |
| Distribution | The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Austral |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica Siemens Healthcare Diagnostics, Mar 9, 2017 |