Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling 1,807 Atellica CH 930 Analyzer systems with software version v1.21.0 SP1 or lower distributed nationwide and globally. The recall addresses a software issue where editing an assay Test Definition and switching to a different assay Test Definition screen without saving changes using the save button may corrupt the assay's test definition settings. This corruption can cause Auto-Rerun or Auto-Dilution results to generate incorrect values—specifically, a result of Zero (0) for quantitative assays or Negative for qualitative assays—if a reagent pack well is not calibrated.
The recall notice does not specify any remedy or action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.
Reason for recall: Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated. Distribution: US Nationwide. Global distribution. Quantity: 1807 Lot/code info: UDI: 00630414002163; All systems with software version v1.21.0 SP1 or lower Serial Numbers: CM01702 CM01708 CM00184 CM00196 CM01051 CM01467 CM00770 CM00815 CM00983 CM01053 CM00802 CM01004 CM01903 CM00526 CM00635 CM00809 CM00733 CM00735 CM01045 CM01050 CM01052 CM01059 CM00420 CM00632 CM00633 CM00209 CM00210 CM01799 CM01590 CM01612 CM01047 CM01048 CM00859 CM00865 CM01624 CM01626 CM00829 CM00830 CM00651 CM00654 CM01603 CM01608 CM01695 CM01701 CM00749 CM00786 CM01567 CM01569 CM01682 CM01683 CM00773 CM01431 CM01474 CM01583 CM01598 CM01602 CM00148 CM00151 CM00152 CM01907 CM01738 CM01739 CM01105 CM00799 CM00800 CM01823 CM01917 CM01409 CM01410 CM01588 CM01600 CM01274 CM01306 CM00947 CM00948 CM01660 CM01661 CM00812 CM00828 CM00820 CM01593 CM01594 CM01585 CM01599 CM01058 CM00421 CM00606 CM00331 CM00333 CM01133 CM01149 CM01619 CM01191 CM01200 CM00769 CM00858 CM01237 CM01259 CM00797 CM00798 CM01589 CM01614 CM00426 CM00427 CM00701 CM00704 CM01264 CM01278 CM01391 CM01512 CM00611 CM00612 CM01735 CM00643 CM00646 CM00831 CM00832 CM01761 CM01772 CM01727 CM01740 CM01745 CM00315 CM00316 CM00123 CM00181 CM01031 P-P1-07 CM00147 CM00432 CM00297 CM00430 CM00780 CM01296 CM00268 CM00271 CM00265 CM00267 CM01759 CM01760 CM01579 CM01611 CM01139 CM00607 CM00625 CM01699 CM01716 CM00884 CM00888 CM00577 CM00631 CM01650 CM00459 CM00510 CM01441 CM01343 CM01394 CM00973 CM00977 CM01586 CM01616 CM01620 CM01621 CM00634 CM00637 CM01400 CM01406 CM00626 CM00627 CM01344 CM01345 CM00418 CM00419 CM00724 CM00628 CM00630
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.