Recall Z-0204-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
| Date | Aug 15, 2019 |
| Status | Terminated |
| Reason | Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2 |
| Root cause | Under Investigation by firm |
| Action | Siemens issued an Urgent Medical Device Correction (UMDC) to US customers via FedEx on August 15, 2019. The UFSN was electronically issued to all OUS Siemens sites, with affected customers, for distribution, as well as regional reporting to their respective local competent authority on August 16, 2019. The UMDC/UFSN explain the behavior(s) to users and provide actions to be taken to correct the behavior. Customers are requested to return the Effectiveness Check Form, in the UMDC/UFSN via fax or email. Siemens Healthcare Diagnostics Inc. has released an updated software (SW) version (V) 1.20.0 |
| Quantity | 88 total US: 54;OUS 34 |
| Distribution | Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System Siemens Healthcare Diagnostics, Inc., Nov 20, 2015 |