Reported Feb 19, 2025 · Ongoing

Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In…

HF Acquisition Co. LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: HF Acquisition Co LLC · 11629 49th Pl W · Mukilteo, WA · 98275-4255

Is this the product you have?

    • Biological
    • Bio52 HealthFirst Mail In Monitoring System
    • 52 Tests
  • Item
    • 1003600. Biological
    • Bio12 HealthFirst Mail In Monitoring System
    • 12 Tests
  • Item1003580
Lot codes and dates

2 of 2 products · 2 lot codes

Recalled lot codes, grouped by product number
ItemUDI-DILot (Expiration)
100360010850065007820
  • 2301060(11/30/2024) 2302261(11/30/2024) 2307261(12/31/2024 2312260(1/31/2025) 2313062(1/31/2025) 2331880(6/30/2025) 2401664(8/31/2025) 2414060(2/28/2026) 2414862(3/31/2026) 2414870(3/31/2026) 2416470(3/31/2026) 2416481(4/30/2026) 24164824/30/2026
100358010850065007813
  • 24211815/31/2026
Amount recalled
4,021

Where it was sold

Why it was recalled

Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.