Recall Z-0780-2019— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0780-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-26

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2018-09-26, terminated 2020-06-24. It names one FDA 510(k) clearance: K151792. Product: Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - 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.. 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.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-09-26
Terminated: 2020-06-24
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K151792 — Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) SystemSiemens Healthcare Diagnostics, Inc.·cleared 2015-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - 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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.