Recall archive / FDA device enforcement
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135. — FDA record Z-1248-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 15, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
- 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.
- Classification
- Class II
- Recalling firm
- TERRAGENE S.A.
- Quantity
- 914 devices in the U.S.
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1248-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of CA and KY.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 5, 2025
- Recall initiation date
- Jan 15, 2025
- Center classification date
- Feb 27, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.