Class 2 Device Recall SPORETRAQ MAILIN SPORE TESTING SERVICE, 12 TESTS

• Date Initiated by Firm: April 13, 2026
• Date Posted: June 05, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2332-2026
• Recall Event ID: 98695
• 510(K)Number: K032914 K050591
• Product Classification: Indicator, biological sterilization process - Product Code FRC
• Product: Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 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
• Code Information: Lot Code: Please see attached spreadsheet listing products that were not incubated per the following requirements : a. Spore strips used in steam sterilizers are incubated for 24 hours b. Spore strips used in chemiclave sterilizers are incubated for 72 hours c. Spore strips used in dry heat or ethylene oxide sterilizers are incubated for 7 days As noted in the previous recall scope question, HealthFirst's Field Correction scope will be expanded to include notifications to all customers in possession of 1023780 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS,1023770 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS or other products serviced by Mesa Labs.
• FEI Number: 3014534
• Recalling Firm/ Manufacturer: HF Acquisition Co LLC; 11629 49th Pl W; Mukilteo WA 98275-4255
• For Additional Information Contact: TRACY MELTON; 800-3311984
• Manufacturer Reason for Recall: Due to incorrect incubation process being performed on product.
• FDA Determined Cause: Under Investigation by firm
• 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 customerservice@healthfirst.com.
• Quantity in Commerce: 0
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRC