Z-1901-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 11, 2025
- Initiation Date
- May 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 units
Product Description
Access Testosterone assay, Catalog Number 33560
Reason for Recall
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.
Distribution Pattern
US State: FL. UAE, Vietnam
Code Information
UDI-DI: 15099590231347; Serial Number: 538081