Recall Z-1248-2025— TERRAGENE S.A.

Name: FDA recall Z-1248-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-15

Class II · Ongoing

Class II FDA medical device recall by TERRAGENE S.A., initiated 2025-01-15. It names one FDA 510(k) clearance: K163646. 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..

Recalling firm: TERRAGENE S.A.
Classification: Class II
Status: Ongoing
Initiated: 2025-01-15
Firm location: Alvear, N/A, Argentina

510(k) clearances named in this recall

1 on FDA's record

K163646 — Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorTerragene S.A.·cleared 2017-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.