Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Reported: November 10, 2021 Initiated: September 22, 2021 #Z-0195-2022
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 149 kits
- Distribution
- US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 149 kits.
Why was this product recalled? ▼
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 10, 2021. Severity: Moderate. Recall number: Z-0195-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11