Recall Z-0195-2022— Siemens Healthcare Diagnostics, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2021-09-22, terminated 2022-08-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861. Reason: Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-09-22
- Terminated
- 2022-08-02
- Firm location
- East Walpole, MA, United States
Product description
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Reason for recall
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.