Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Biological Recalled by HF Acquisition Co LLC Due to Spore test strip monitoring system, designed for routine...

Date: December 11, 2024
Company: HF Acquisition Co LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact HF Acquisition Co LLC directly.

Affected Products

Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580

Quantity: 4,021

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (50 states)Not affected

About HF Acquisition Co LLC

HF Acquisition Co LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report