Siemens Healthcare Diagnostics Inc, ACHC 22-06, Atellica CH Iron 2

The purpose of this communication is to inform you of an issue with the product indicated in Table 1 above and provide instructions on actions that your laboratory must take. Siemens Healthcare Diagnostics Inc. has confirmed the potential for Atellica CH Iron_2 reagent carryover to impact Microalbumin_2 (μALB_2) results. Falsely elevated μALB_2 results are observed when the assay is processed immediately following an Iron_2 test on the Atellica CH analyzer (See Table 2). This issue can impact μALB_2 results for quality control (QC), patient samples and calibrators. Investigation of this issue indicates that use of Reagent Probe Cleaner 2 (RPC2) wash is an effective mitigation in preventing Iron_2 reagent carryover into μALB_2. For customers operating with Atellica Software v.1.25.2 and lower, the resolution of this issue will be implemented in Atellica Software v1.25.3 which will be available soon. In the interim, please follow the instructions in the “Additional Information” section. Customers who are operating with Atellica Software v1.26 will receive further information when a software update to resolve the issue is available. For laboratories operating with Atellica Software v1.25.2 and below and Atellica Software v1.26 follow the workaround instructions in the “Additional Information” section until a future version of software is available.