ACCESS SARS-CoV-2 Antigen recall
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Why was ACCESS SARS-CoV-2 Antigen recalled?
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
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?
All Lots
- Product
- ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 3,672 unitsin total
- Distribution
- US Nationwide Distribution in the states of Alabama Alaska Arizona Arkansas California Connecticut Delaware Florida Georgia Idaho Illinois Indiana Iowa Kentucky Louisiana Maine Maryland Massachusetts Michigan Mississippi New Hampshire New Jersey New York North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico Tennessee Texas Virginia West Virginia, Wisconsin OUS: New Zealand, Libya
- Recall date
- August 18, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)