Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device Recalled by TERRAGENE S.A. Due to Error in the IFU lists an incorrect incubation...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact TERRAGENE S.A. directly.
Affected Products
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Quantity: 914 devices in the U.S.
Why Was This Recalled?
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About TERRAGENE S.A.
TERRAGENE S.A. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report