HF Acquisition Co LLC recalls Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE

Due to incorrect incubation process being performed on product.

On 04/13/2026, the firm emailed an "URGENT: Medical Device Field Correction" Letter to customers informing them that the firm has identified a laboratory testing service error associated with 1023780 SporeTraq" Mail-In Spore Testing Service, 52 Tests affecting customers using Dry Heat, Chemiclave and Ethylene Oxide autoclave types. Specifically, the incubation criteria applied to the test samples may not have complied with the above requirement for the respective autoclave type. Failure to adhere to appropriate incubation criteria impacts the validity of sterilization process followed at customer locations. Customers are instructed to: 1. Log into your OnTraq" account at ontraq.healthfirst.com. 2. A banner will appear stating ACTION REQUIRED: Review to confirm or update your autoclave types. Go to the Confirmations Page. prompting you to verify the autoclave type. 3. Verify that the autoclave type is accurate by clicking the "Go to the Confirmations Page" hyperlink or navigating to "Confirm Autoclave Type" tab - If all information is accurate as it is, click on the CONFIRM button. - If not, edit by clicking the pencil icon next to the relevant data field, enter the updated information and click on the SAVE button. - If the autoclave is no longer in use, click the DEACTIVATE button and confirm the action in the pop-up window. 4. If the above actions were completed prior to receipt of this notification via email, mail or telephone, no further action is required. For questions - contact Customer Service at 855-476-1342 or email us at customerservice@healthfirst.com.

• FDA enforcement recordOfficial FDA database entry for Z-2332-2026
• FDA 510(k) clearance · K032914The device's official FDA premarket clearance record
• FDA 510(k) clearance · K050591The device's official FDA premarket clearance record
• FDA device classification · FRCOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.2800The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find HF Acquisition Co LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.