Access Testosterone assay recall: Contamination
Access Testosterone assay, Catalog Number 33560
Why was Access Testosterone assay recalled?
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.
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?
UDI-DI: 15099590231347; Serial Number: 538081
- Product
- Access Testosterone assay, Catalog Number 33560
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 70 units
- Distribution
- US State: FL. UAE, Vietnam
- Recall date
- June 11, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)