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STERLINK™
Plasmapp Co.,Ltd. · Model BT96 · UDI-DI 08800066500184
1
510(k) clearances
1,469
Adverse events
46
Recalls
42
Facilities
Description
Terragene Bionova® SCBI(BT96) is a self-contained biological indicator inoculated with viable 10^6 Geobacillus sterotheromophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydorgen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60 degree celsius.
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 cycles, the potential |
| 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 cycles, the potential |
| 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 cycles, the potential |
| 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 cycles, the potential |
| 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 cycles, the potential |
| 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 cycles, the potential |
| 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 spore test results t |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.