TERRAGENE recalls ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device (REF 73135) with incorrect incubation time in instructions. This may lead to inaccurate test results if used without correction.
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
TERRAGENE is recalling a specific steam bioprocess challenge device due to an error in the instructions that lists a 20-minute incubation time instead of the correct 60 minutes. This could cause inaccurate test results if the device is used without correcting the time.
The device's instructions incorrectly list a 20-minute incubation time instead of the correct 60 minutes. If users follow the wrong time, test results may be inaccurate. This error does not cause physical harm but could lead to incorrect conclusions in laboratory testing.
Users of the ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device (REF 73135) with lot numbers F40062, F40064, F40072, F40074, F40101, or F40116 are affected. Laboratory technicians and quality control personnel using this device are most at risk.
Check for lot numbers F40062, F40064, F40072, F40074, F40101, or F40116 on the device's packaging. The device has a unique identifier (UDI-DI) starting with 07798375772624 or 07798375772877 and includes IFU Rev.A R0.
Review the instructions for the correct incubation time (60 minutes) to ensure accurate test results.
The instructions list an incorrect incubation time of 20 minutes instead of the correct 60 minutes, which could lead to inaccurate test results.
Check the lot numbers on the device packaging to see if it is affected. If it is, review the instructions for the correct incubation time.
The recall does not provide a fix; users must follow the correct incubation time of 60 minutes as stated in the updated instructions.
We’ve drafted a message you can send TERRAGENE to request your refund or repair — edit it as you like.
Subject: Recall Z-1248-2025 — TERRAGENE TERRAGENE Hello, I own a TERRAGENE that is covered by recall Z-1248-2025 from TERRAGENE. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
