Siemens Healthcare Diagnostics Inc.,ASI 22-01, Atellica IM 1300 and IM 1600 Analyzers

Siemens Healthcare Diagnostics Inc. has confirmed that Atellica IM analyzers listed in Table 1 may produce inconsistent results for Atellica IM T3 Assay (Triiodothyronine) reagent kit lots ending in numbers below 244 after scanning the Master Curve (MC) Card for reagent lots ending in 244 or above. If your facility is only using T3 kit lots ending in 244 or above, you are not impacted, and no further action is required.
The issue is caused by a modification to the Test Definition (TDef) that was introduced with Atellica IM T3 kit lots ending in 244. When multiple reagent lots are present on the system, after the 2D TDef barcode in the MC Card for a kit lot ending in 244 or above (TDef version 1.4) has been scanned, if the system uses a kit lot number lower than lots ending in 244 to process results, you may observe, imprecision in the range of -50% to +117% across the entire analytical measuring
range, inconsistent QC results (out of range) or a calibration failure.
No other assay is impacted as the TDef update was specific for the T3 assay. Siemens Healthcare Diagnostics has determined that reagent kit lots ending in lot numbers below 244 are not compatible with the design of the T3 TDef v1.4 that is used with reagent kit lots ending in 244 and above. All reagent kit lots ending in numbers below 244 must be used with the TDef that is on the MC Card for the corresponding lot (TDef v1.3 or below).
Please refer to the instructions in the ‘Actions to be Taken’ section below on actions that your laboratory must take when running the T3 assay until all lots ending in numbers below 244 have been fully consumed or expired.