Recall archive / FDA device enforcement
Access Testosterone assay, Catalog Number 33560 — FDA record Z-1901-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 5, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Access Testosterone assay, Catalog Number 33560
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 70 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1901-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 15099590231347; Serial Number: 538081 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US State: FL. UAE, Vietnam
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 11, 2025
- Recall initiation date
- May 5, 2025
- Center classification date
- Jun 2, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.