—#184952

Product

Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: 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: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K151792
Affected lot / code info: Software (SW) versions V1.23.2 (SMN 11469032) or lower

Why it was recalled

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Siemens has issued an Urgent Medical Device Correction letter (UMDC ASW21-02.A.US) and Urgent Field Safety Notice, (UFSN ASW21-02.A.OUS) to all affected Customers stating reason for recall, health risk and action to take: Software version 1.24.x correcting the issues will be released when available and all systems will be updated. The following actions must be taken until your system has been updated to software version 1.24 or higher which resolves the issues listed below. Siemens Healthineers will notify you when an updated software version is available. Issue Number 1: Patient sample may be run on analyzer where it was disabled. 1. When reporting results, ensure that the result for the assay that is disabled on one analyzer, came from a system where the assay had not been disabled and all QC results are within the laboratory acceptable range. 2. To check if an assay is enabled or disabled, navigate to Setup/>/Test Definition/>/Assay List/>/CH or IM tab./An assay is/enabled if the box is checked in the column/for an analyzer. 3. The Audit Trail screen (System->Logs->Audit Trail.Log) can be checked to see if an assay had been disabled in the past. Issue Number 2: Bypass mode patient samples may be run. 1. Always ensure that the system covers are properly physically closed and latched. The lock glyph on the System > Status/screen for an analyzer indicates whether the cover is locked or/unlocked. Ensure that there are no yellow unlocked glyphs displayed. 2. Before starting/sample processing,/check/the Operator Event log and ensure that the following error code is not present: 03 600 00 44: A cover is open with the Service Bypass Tools in place. Ensure all operators are clear of moving subassemblies to avoid personal injury or system damage. Corrective Action: Contact the local technical support provider for assistance./ Refer to the online help Alerts section 03 IM Event Troubleshooting if the error code is present. Issue Number

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, Bahrain, 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, Vatika City, Vietnam.

Timeline

Recall initiated: 2020-12-02
Terminated: 2024-06-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184952. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.