ADVIA Centaur SARS-CoV-2 Antigen Assay Recalled for Insufficient Validation Data
Siemens Healthcare Diagnostics is recalling 261 ADVIA Centaur SARS-CoV-2 Antigen Assay test kits distributed nationwide because the FDA determined that validation data submitted for emergency authorization was insufficient to confirm the assay's effectiveness.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a diagnostic test distributed nationwide prior to validation deficiency identification. An unvalidated COVID-19 diagnostic assay represents a risk-of-harm product, as inadequate validation could result in inaccurate test results. No illnesses or injuries have been reported, which per the severity rubric caps the score at 3.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 261 units of the ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit). The kits were distributed nationwide to 15 U.S. states and territories. Two lots are affected: Lot #44990001 (expires October 7, 2021) and Lot #60408003 (expires November 12, 2021).
The FDA determined that data provided in the Emergency Use Authorization (EUA) application was insufficient to determine that the assays were adequately validated for their intended use. This validation gap means the FDA could not confirm from the submitted data that the test works as designed, creating a potential risk of inaccurate test results.
No illnesses or injuries have been reported in connection with this recall. Laboratories and healthcare facilities using these kits should discontinue use immediately and contact Siemens Healthcare Diagnostics for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- inadequate-validation
- diagnostic-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot # 44990001
- Exp. Date 2021-10-07
- UDI # (01)00630414611747(10)44990001(17)20211007. Lot # 60408003
- Exp. Date 2021-11-12
- UDI # (01)00630414611747(10)60408003(17)20211112.
Distribution
Distributed nationwide across the United States.
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