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HF Acquisition Co LLC recalls Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In
Recalled February 19, 2025 · FDA recall Z-1141-2025 · HF Acquisition
Hazard
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account. · FDA Class II
Units
4,021
Sold at
US: WI, FL, NY, CO, NJ, OH, IN, CA, WA, TX, AZ, MD, MN, NC, MI, MS, ID, TN, KS, SC, RI, LA, GA, PA, NH, UT, VA, MA, NV, MO, IL, SD, AR, OR, HI, NE, DC, CT, NM, ND, MT, OK, AL, VT, WY, KY, ME, IA, WV, AK
Description
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.
Product
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
Manufacturer(s)
HF Acquisition Co LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →