Recall Z-0449-2022 ยท JGS Electrode, Ion Specific, Sodium
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000
| Date | Nov 18, 2021 |
| Status | Open, Classified |
| Reason | (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results |
| Root cause | Software design |
| Action | Siemens issued Urgent Medical Device Correction (UMDC), ASW22-01.A.US, to US customers by FedEx beginning on November 18th, 2021. An Urgent Field Safety Notice (UFSN), ASW22-01.A.OUS, was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 2021/11/18. Letter states reason for recall, health risk and action to take: The following actions must be taken until your system has been updated to a software version which resolves the issues mentioned in Table 2 above. Siemens Healthineers wil |
| Quantity | 2,980 units |
| Distribution | Nationwide Foreign: AU DE AE TR BG CL IN CZ BR ES KE CN PL SA BE IQ IT CW SE AR CO GR SK EE KR JP UY DK FR GB VN CA BD MX TH DZ PT RU ZA PK HU NL VA NO AT IR LV EG PH SG MY IL FI HR MA KW CH TW BH AL BF UG NZ OM HK QA PE EC IE GP LY LT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151767 | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Br Siemens Healthcare Diagnostics, Inc., Dec 11, 2015 |