Recall Z-0190-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
| Date | Jun 29, 2018 |
| Status | Terminated |
| Reason | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x |
| Root cause | Software design |
| Action | Siemens issued an Urgent medical Device Correction, (UMDC ASW18-02.A.US) and Urgent Field Safety Notification (UFSN ASW18-02.A.OUS) on 6/29/18, via FedEx to the US Customer and via email distribution to countries Outside US (OUS). The field action letters explain the behaviors and informed Customers of action to be taken to prevent the behaviors from occurring. Siemens has released an updated software (SW) version (V), 1.14, which corrects the reported behaviors. |
| Quantity | 35 |
| Distribution | Nationwide Foreign: Australia Austria Belgium Brazil Canada Croatia Czech Republic Denmark France Germany Greece Italy Japan Malaysia Mexico Netherlands Norway Poland Republic Korea Singapore Spain Sweden Switzerland U.A.E. United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica Siemens Healthcare Diagnostics, Mar 9, 2017 |