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Recall Observatory FDA recall evidence

Device product

Access Testosterone assay, Catalog Number 33560

Z-1901-2025

May 05, 2025

Class II

Product summary

Firm
Beckman Coulter, Inc.
Event
Event 96824
Status
Ongoing
Classification
Class II
Quantity
70 units
Official record key
device-enforcement:Z-1901-2025

Official wording

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.

Code information: UDI-DI: 15099590231347; Serial Number: 538081

Distribution pattern: US State: FL. UAE, Vietnam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.