Recall Z-0862-2020 ยท JGS Electrode, Ion Specific, Sodium
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens.
| Date | Oct 11, 2019 |
| Status | Terminated |
| Reason | On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids, therefore the system will utilize default nominal values instead of lot specific IMT fluid concentration values for calculation of the calibrations and results for the Na, K, and Cl methods. |
| Root cause | Under Investigation by firm |
| Action | The firm, Siemens Healthineers, sent an "Urgent Field Safety Notice ASW20-01.A.OUS" dated October, 2019 to its customers. The notice described the product, the problem and the actions to be taken. Actions to be Taken by the Customer 1. Scan the barcodes for IMT system fluids Std A and Std B for Na, K, and Cl at the system workstation using the manual barcode reader. Do not scan these barcodes at the module console. " When available, software v1.20.1 will be delivered as follows: " For systems running software v1.19.0 or higher, the software will be delivered electronically through the Sieme |
| Quantity | 1528 |
| Distribution | The products were distributed to the following foreign countries: Argentina, Belgium, Brazil, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, and Vietnam. No affected products distributed in the United States. |
| 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 |