FDA Recall Open, Classified

Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

Recall: Z-2331-2026 · Initiated April 13, 2026

Recall

Recall Number: Z-2331-2026
Event Number: 98695
Firm: HF Acquisition Co LLC
FEI Number: 3014534
Product Code: FRC
Status: Open, Classified
Root Cause: Under Investigation by firm
Initiated: April 13, 2026
Posted: June 5, 2026
Address: 11629 49th Pl W, Mukilteo, WA, 98275-4255

Description

Reason

Due to incorrect incubation process being performed on product.

Action

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 [email protected].

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, UT, VA, VT, WA, and WI.

Quantity

2210