Recall Z-0474-2021
Siemens Healthcare Diagnostics, Inc. · initiated October 26, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Software version: V1.23.1 or lower UDI: 00630414002026
Reason for recall
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
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0474-2021
- Initiated
- October 26, 2020
- Terminated
- April 19, 2024
- Product code
- JLW – Radioimmunoassay, Thyroid-Stimulating Hormone
- Quantity
- US: 214 units; OUS: 1082 units
- Distribution
- 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…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Tarrytown, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0473-2021 Class II | Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to…Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a… | 10/26/2020Terminated |