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Bionova®
TERRAGENE S.A. · Model BT20 · UDI-DI 07798164673545
10
510(k) clearances
1,469
Adverse events
40
Recalls
42
Facilities
Description
Self-contained Biological Indicator for monitoring steam sterilization processes.
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 spore test results t |
| 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 Super Rapid Readout Stea |
| 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 Super Rapid Readout Stea |
| 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 Super Rapid Readout Stea |
| 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 Super Rapid Readout Stea |
| 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 , some BIs within the lot |
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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.