Reported Mar 5, 2025 · Ongoing
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Terragene S.a.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TERRAGENE S.A. · Ruta Nacional N 9, Km 280, Cp 2130 · Alvear, N/A · N/A
Is this the product you have?
- ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
- Lot codes and dates
- Lot numbersF40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0
- Amount recalled
- 914 devices in the U.S.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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