—#168428

Product

Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - 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 clinical use.

FDA product code: JIT — Calibrator, Secondary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K161954
Affected lot / code info: Software in V 1.14.2 and lower.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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 updated with software version- SW V1.15 which resolves issues.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: 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, Poland, Portugal, Republic Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, U.A.E., United Kingdom, Vietnam.

Timeline

Recall initiated: 2018-09-26
Terminated: 2020-06-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168428. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.