ASP BIOTRACE Auto Read 60 Steam BI Process Challenge recall
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Why was ASP BIOTRACE Auto Read 60 Steam BI Process Challenge 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.
- Product
- ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
- Recalling firm
- TERRAGENE S.A.
- Quantity
- 914 devices in the U.S.
- Distribution
- US Nationwide distribution in the states of CA and KY.
- Recall date
- March 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)