—#184385

Product

Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000

FDA product code: JLW — Radioimmunoassay, Thyroid-Stimulating Hormone
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K151792
Affected lot / code info: Software version: V1.23.1 or lower UDI: 00630414002026

Why it was recalled

Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Siemens issued an Urgent Medical Device Correction (UMDC ASW21-01.A.US) via Fed'X to US Customers on 10/26/20 and Urgent Field Safety Notice, (UFSN ASW21-01.A.OUS) via electronic distribution to regional countries for implementation Outside US (OUS) The UMDC and UFSN explain the behaviors that can occur and instructs customers on actions to be taken for the issues described in the communication. Customers are requested to return the attached effectiveness check form via fax or email. A software version correcting the issues will be released when available and all systems will be updated.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Poland, Portugal, Qatar Republic, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay, Vatikancity, Vietnam.

Timeline

Recall initiated: 2020-10-26
Terminated: 2024-04-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184385. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.