Recall Z-2028-2021 · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
| Date | May 13, 2021 |
| Status | Open, Classified |
| Reason | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay. |
| Root cause | Component design/selection |
| Action | Siemens issued an Urgent Medical Device Correction (UMDC) ASI21-02.A.US and Urgent Field Safety Notice (UFSN) ASI21-02.A.OUS on 5/13/2021 to all affected customers informing them of the issue and providing instructions the customer must follow until their analyzer is updated with replacement valves that do not have the manufacturing defect. Siemens will release the replacement valves and will begin installation at customer sites in June 2021. Letter states: Actions to be Taken by the Customer The following actions must be taken until your system has been serviced to replace any leaking compon |
| Quantity | US: 123 OUS: 751 |
| Distribution | Nationwide Foreign: Country Name Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile Colombia Croatia Cura¿ao Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece Hungary India Indonesia Iraq Ireland Israel Italy Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System Siemens Healthcare Diagnostics, Inc., Nov 20, 2015 |