ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Reported: March 5, 2025 Initiated: January 15, 2025 #Z-1248-2025
Product Description
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
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.
Details
- Recalling Firm
- TERRAGENE S.A.
- Units Affected
- 914 devices in the U.S.
- Distribution
- US Nationwide distribution in the states of CA and KY.
- Location
- Alvear, N/A
Frequently Asked Questions
What product was recalled? ▼
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.. Recalled by TERRAGENE S.A.. Units affected: 914 devices in the U.S..
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2025. Severity: Moderate. Recall number: Z-1248-2025.
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