TERRAGENE S.A. 2025-03-05 Health serious FDA
Health · FDA · Recall #FDA-Z-1248-2025
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135. Recall
Issued March 5, 2025 · TERRAGENE S.A.
In March 2025, TERRAGENE S.A. recalled the ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
What you should do
- 1 Stop using ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact TERRAGENE S.A. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- TERRAGENE S.A.
- Category
- Health
- Recall date
- March 5, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of CA and KY.
- Recall number
- FDA-Z-1248-2025
- Made in
- Argentina
- Issuing agency
- FDA
In context
- TERRAGENE S.A. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.