Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52

FDA device recall Z-2331-2026 · posted 2026-06-05 · Open, Classified

Recall details

Recalling firm

HF Acquisition Co LLC

Reason for recall

Due to incorrect incubation process being performed on product.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FRC

Quantity affected

2210

Distribution

U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX,

Date initiated

2026-04-13

Date posted

2026-06-05

Location

Mukilteo, WA

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