Atellica IM SARS-CoV-2 Antigen Assay recall
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Why was Atellica IM SARS-CoV-2 Antigen Assay recalled?
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 44989001 - Exp. Date 2021-10-07, UDI # (01)00630414611846(10)44989001(17)20211007; Lot # 60407003 - Exp. Date 2021-03-22, UDI # (01)00630414611846(10)60407003(17)20211112.
- Product
- Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 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.
- Recall date
- November 10, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)