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Indicator, Biological Sterilization Process
FDA product code FRC · Class 2 · General Hospital
495
Registered devices
1,469
Adverse events
40
Recalls
206
510(k) clearances
Devices with this code
Dual Species BI Strip — CROSSTEX INTERNATIONAL, INC.VERIFY Assert — STERIS CORPORATIONSmart-Read EZTest Steam — MESA LABORATORIES, INC.Smart-Read EZTest Steam — MESA LABORATORIES, INC.SteriTec EZTest Steam Biological Indicator — STERITEC PRODUCT MFG. CO., INC.Dual Spore Strips - Control — MESA LABORATORIES, INC.Propper Duo Spore Biological Indicators — PROPPER MANUFACTURING COMPANY, INC.PATTERSON — PATTERSON DENTAL SUPPLY, INC.Bionova® — TERRAGENE S.A.BI-OK Ethylene Oxide Gas Vials — PROPPER MANUFACTURING COMPANY, INC.SmartPractice — Smarthealth, Inc.Bionova® — TERRAGENE S.A.Celerity — STERIS CORPORATIONHu-Friedy MFG Co., LLC. — HU-FRIEDY MFG. CO., LLCCelerity — STERIS CORPORATIONHenry Schein — HENRY SCHEIN, INC.VERIFY — STERIS CORPORATIONVERIFY Assert — STERIS CORPORATIONVERIFY — STERIS CORPORATIONBionova® — TERRAGENE S.A.PATTERSON — PATTERSON DENTAL SUPPLY, INC.VERIFY — STERIS CORPORATIONBi-Weekly Testing Service — MESA LABORATORIES, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2023-12-07 | TERRAGENE S.A. | Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products. |
| 2023-08-22 | 3M Company - Health Care Business | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Supe |
| 2023-08-22 | 3M Company - Health Care Business | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Supe |
| 2023-08-22 | 3M Company - Health Care Business | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Supe |
| 2023-08-22 | 3M Company - Health Care Business | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Supe |
| 2022-12-12 | Steris Corporation | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , som |
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