RegWardenFDA facility compliance records
Company

ASP Global, LLC

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2025: 2 recalls20172018201920202021202220232024220252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-09-26
    Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
  • Class IIOngoing2025-05-05
    All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unne…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “ASP Global, LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9066528-asp-global-llc/

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