ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Summary
The FDA issued a Class II for ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135. by TERRAGENE S.A.. Reason: 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
Source
Device Recall
External ID
Z-1248-2025
Action Date
2025-03-05
Status
Ongoing
Category
device
Product Description
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Lot/Code Info: Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.
Quantity Affected: 914 devices in the U.S.
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.
Distribution
US Nationwide distribution in the states of CA and KY.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-15
Company
Alvear, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
TERRAGENE S.A. has 8 FDA actions in our database, including 3 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TERRAGENE S.A.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TERRAGENE S.A. have FDA actions?
TERRAGENE S.A. has 8 FDA actions in our database, including 3 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1248-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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