Recall Z-0581-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer
| Date | Sep 23, 2019 |
| Status | Terminated |
| Reason | Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher. |
| Root cause | Software design |
| Action | Siemens issued an Urgent medical Device Correction, (UMDC ASW19-06.A.US) and Urgent Field Safety Notification (UFSN ASW19-06.A.OUS) to all affected Customers via Certified Mail (domestic) and e-mail (international) beginning on 2019-09-23. It included the following instructions to the user: Actions to be Taken by the Customer 1. Do not order Reagent Pack Calibration (C0 Adjust) while the Reagent Lot calibration is in progress. 2. Always run QC after calibration before running patient samples. If QC is ordered with calibration and it recovers out of range high, the calibration status will be 'A |
| Quantity | 1432 |
| Distribution | Distributed to accounts located in AL AZ AR CA CO FL GA IL IN IA KS KY LA MA MI MN MS NE NV NH NJ NM NY NC OH OR PA SC TN TX UT WA WV DC PR. Foreign distribution to AR AU AT BS BD BE BR BG CA CL CO CW CZ DK EG FI FR DE GR HU IN IR IE IL IT JP KW LV MY MX NL NG NO CN PK PH PL PT QA KR RO RU SA SG SK |
| 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 |