Recall Z-0781-2019 ยท JIT Calibrator, Secondary
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for c
| Date | Sep 26, 2018 |
| Status | Terminated |
| Reason | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer; Atellica Sample Handler Prime |
| Root cause | Software design |
| Action | Siemens Healthcare Diagnsotics issue an Urgent Medical Device Correction (UMDC) was issued to US customers via Fed-Ex on September 26, 2018. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities. The letter explains the reasons, observed behaviors, risk to health, actions to be taken. Review the letter with the Medical Director. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. The system will be updat |
| Quantity | 264 |
| Distribution | Worldwide distributions - US Nationwide and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, |
| 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 |