HF Acquisition Co LLC: Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580

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.

Details from the source

Reason for recall: 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. Distribution: 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 Quantity: 4,021 Lot/code info: Item/UDI-DI/Lot(Expiration): 1003600/10850065007820/ 2301060(11/30/2024) 2302261(11/30/2024) 2307261(12/31/2024 2312260(1/31/2025) 2313062(1/31/2025) 2331880(6/30/2025) 2401664(8/31/2025) 2414060(2/28/2026) 2414862(3/31/2026) 2414870(3/31/2026) 2416470(3/31/2026) 2416481(4/30/2026) 2416482(4/30/2026) 1003580/10850065007813/2421181(5/31/2026)

UPC codes

10850065007820, 10850065007813

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.