Recall Z-1945-2016 ยท GKZ Counter, Differential Cell
Sysmex Corporation
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
| Date | Jun 10, 2016 (initiated Dec 18, 2014) |
| Status | Terminated |
| Reason | There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values. |
| Root cause | Device Design |
| Action | Sysmex Corporation sent a Product Notification Field Correction letter were to all affected customers of record. The letters included instructions for customers to: 1) Review results with an unexpected increase in Hgb, MCH, MCHC, and/or PLT-I. The increase may result in a low or normal value being artificially elevated to either a normal result or a result above the reference ranges, or a high value being artificially increased. There is negligble impact to the RBC when the issue occurs; 2) The relationship with an elevated Hgb would cause the indices (MCH and MCHC) values to appear to be abn |
| Quantity | 1,137 units (US) 54 units (Canada) 9 inventory |
| Distribution | Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, 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, WY + District of Columbia + Guam; Internationally to Australia, Bahrain, Bang |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112605 | SYSMEX XN-SERIES Sysmex America, Inc., Oct 19, 2012 |