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Indicator, Biological Sterilization Process
FDA product code FRC · Class 2 · General Hospital
499
Registered devices
1,469
Adverse events
46
Recalls
206
510(k) clearances
Devices with this code
Bionova® — TERRAGENE S.A.VERIFY — STERIS CORPORATIONVERIFY Assert — STERIS CORPORATIONAttest™ — 3M COMPANYGetinge Assured AccuView Biological Test Pack with 5 Controls — STERITEC PRODUCT MFG. CO., INC.Excelsior Scientific — True Indicating LLCPQ Autoclave Pouches (3-1/4" x 12") Clear Film — PEARSON DENTAL SUPPLIES, INC.SPORVIEW PLUS SELF-CONTAINED STARTER KIT — SPS Medical Supply Corp.McKesson — MCKESSON MEDICAL-SURGICAL INC.Spore Check System — OSHA REVIEW INCSTERRAD™ — ADVANCED STERILIZATION PRODUCTS SERVICES INC.SporAmpule™ Biological Indicator — CROSSTEX INTERNATIONAL, INC.ExpoSure Steam — MESA LABORATORIES, INC.BI-OK Ethylene Oxide Gas Vials — PROPPER MANUFACTURING COMPANY, INC.Attest™ — 3M COMPANYAttest™ — 3M COMPANYAttest™ — 3M COMPANYDefend — YOUNG MYDENT, LLCSteriTec Smart-Read Biological Test Pack with Instant Readout Integrator — STERITEC PRODUCT MFG. CO., INC.BIOTRACE™ — TERRAGENE S.A.BIOTRACE™ — TERRAGENE S.A.VERIFY — STERIS CORPORATIONSTERLINK™ — Plasmapp Co.,Ltd.Single Species BI Strip — CROSSTEX INTERNATIONAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization c |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization c |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization c |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization c |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization c |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization c |
| 2026-04-13 | HF Acquisition Co LLC | Due to incorrect incubation process being performed on product. |
| 2026-04-13 | HF Acquisition Co LLC | Due to incorrect incubation process being performed on product. |
| 2025-01-15 | TERRAGENE S.A. | Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes. |
| 2024-12-11 | HF Acquisition Co LLC | Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause |
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