Aptima CMV Quant Assay recall
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent…
Why was Aptima CMV Quant Assay recalled?
Use of assay along with plasma specimen may result in error code which would invalidate sample.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 #: 402941/ UDI:15420045514553
- Product
- Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent…
- Recalling firm
- Hologic, Inc.
- Quantity
- 684 kits
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, ID, IL, MD, MI, MO, TN, TX, WI and the countries of Australia, Germany, Denmark, Spain, France, Great Britain, Italy, Norway, Qatar, Sweden.
- Recall date
- April 3, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)