FDA-Device2026-06-17Class IIPROCESSING DEFECT
SporeTraq Mail-In Spore Testing Service recalled for incorrect incubation process
OTHERNationwide distribution
SporeTraq spore testing service recalled for incubation error
SporeTraq Mail-In Spore Testing Service kits were processed with incorrect incubation times, which may affect the accuracy of sterilizer efficacy test results. The kits are used by healthcare facilities to verify that their sterilization equipment is working properly.
- If you use SporeTraq testing services, contact HF Acquisition Co LLC or Mesa Labs for information about affected lot codes and corrective actions.
- Do not rely on test results from affected kits to confirm sterilizer efficacy until you receive further guidance.
- Healthcare facilities should review their sterilization validation records and consult with the manufacturer about verification of results.
Hazard
Due to incorrect incubation process being performed on product.
Sold states
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.
Affected count
0
Manufactured in
11629 49th Pl W, N/A, Mukilteo, WA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2332-2026More HF Acquisition Co LLC recalls
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