CLASS II ONGOING Device recall · Reported 5 Mar 2025 · FDA Enforcement Report
ASP Biotrace Auto Read 60 Steam BI Process Challenge Device recalled
Terragene is recalling ASP Biotrace Auto Read 60 Steam BI Process Challenge Device, distributed nationwide in the US. The recall was initiated on 15 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1248-2025
- FDA event ID
- 96176
- Recalling firm
- Terragene, Alvear, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Jan 2025
- FDA classified
- 27 Feb 2025
- Reported
- 5 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Jan 2025 | Recall initiated by company | |
| 27 Feb 2025 | Classified by FDA | +43 days |
| 5 Mar 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Product as listed by the FDA
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Where it was distributed
US Nationwide distribution in the states of CA and KY.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.
Where was it sold?
US Nationwide distribution in the states of CA and KY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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