Class 2 Device Recall Atellica CH 930 Analyzer

• Date Initiated by Firm: February 27, 2020
• Create Date: April 24, 2020
• Recall Status: Terminated on October 25, 2021
• Recall Number: Z-1797-2020
• Recall Event ID: 85268
• 510(K)Number: K151767
• Product Classification: Electrode, ion specific, sodium - Product Code JGS
• Product: Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
• Code Information: 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 CM00958 CM00979 CM00971 CM00481 CM00482 CM01066 CM01118 CM01923 CM01675 CM01241 CM01253 CM01242 CM01255 CM01247 CM01268 CM01801 CM01528 CM01529 CM00864 CM00867 CM00400 CM00407 CM01455 CM01459 CM00851 CM00852 CM01499 CM00330 CM00343 CM00344 CM01513 CM01553 CM01818 CM01819 CM01597 CM00905 CM00915 CM00917 CM00918 CM00457 CM00458 CM01065 CM01239 CM01245 CM00639 CM00640 CM00746 CM00747 CM00748 CM01694 CM01696 CM00182 CM00183 CM01401 CM01423 CM00422 CM00423 CM00424 CM00425 CM00781 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• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: Ranjan Sadarangani; 914-631-8000
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: An Urgent Medical Device Correction notification letter dated 2/27/20 was sent to customers. The purpose of this communication is to inform you of the issues listed in Table 2 below, that can occur on the Atellica CH 930 Analyzer, installed with Atellica Solution software (SW) versions v1.21.0 SP1 or lower and provide instructions on actions your laboratory must take. These issues will be corrected in SW v1.22.0 and v1.21.11, which will be available soon. Actions to be Taken by the Customer The following actions must be taken until your system has been updated to software version v1.22.0 (or V1.21.11 for Atellica Solution with decapper modules) or higher which resolves the issues listed above. 1. When making modifications to an assays Test Definition settings on the Setup>Test Definition>CH Test Definition screen, always follow the instructions outlined in the Atellica Solution online help 1.20 instructions Editing Assay Identification Parameters in CH Test Definition. Each Test Definition must be saved using the Save button on the CH Test Definition screen before starting modifications on another assays Test Definition. After changing any setting on the Definition, Calculation, or Calibration tabs of the CH Test Definition screen, select Save and then OK. Verify that QC results are not affected, and that results, units, and flags are reported correctly for any Test Definition that has been updated before running patient samples. 2. Ensure all reagent packs have a valid calibration (all wells) before running samples. This information is available on the screen Calibration > Calibration Overview. Refer to the Atellica Solution online help 1.20 instructions, Viewing Assay Reagent Calibration Order Status . When available, software v1.22.0 and/or v1.21.11 will be delivered as follows: For systems running software v1.19.0 or higher, that are connected to the Smart Remote Service (SRS), the software will be delivered electronically
• Quantity in Commerce: 1807
• Distribution: US Nationwide. Global distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JGS