Z-1248-2025Class II

ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135

Name: Z-1248-2025 ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135
Creator: Terragene S.a.
Published: 2025-01-15
License: https://open.fda.gov/license/

Terragene LLC / initiated 2025-01-15 / Open, Classified / root cause: labeling and UDI

FDA source

TERRAGENE S.A. began a recall of ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135 on 2025-01-15. FDA classified it as Class II and gives the reason as "Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1248-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-15
Posted: 2025-02-27
Recalling firm: Terragene LLC
Product: ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Product code: FRC Indicator, Biological Sterilization Process
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: The recalling firm issued an email on 1/15/2025 to the main office of the distributor with an attached Distributor Customer Communication letter dated 1/15/2025, an Acknowledgement and Receipt Form, an updated IFU (Rev.B R01), and a User Letter for the distributor to issue to their customers. The letter to the distributor explains that all product is affected that contains version Rev.A R0 of the IFU because a discrepancy was identified in that version. The Distributor is to review their inventory records for the affected product, identify customers that received or may have received the devices and report it to the recalling firm through the provided Acknowledgement and Receipt Form via email. The Distributor is informed the product can be used according to the enclosed updated IFU (Rev.B R01). The Distributor was requested to notify their customer by using the enclosed User Letter and include the updated IFU with the User Letter. The Distributor is also informed they can continue distribution of their inventory by sending the digital user letter and the updated digital IFU with each delivery. An updated printed IFU will also be made available to users upon request. The User Letter was similar to the Distributor letter except that it instructs the user to discard older version of the IFU (Rev.A R0 and use the product according to the IFU attached to the letter and available on the firm's website. an Acknowledgement and Receipt Form was also enclosed for completion and return.
Quantity in commerce: 914 devices in the U.S.
Distribution: US Nationwide distribution in the states of CA and KY.
Product codes and lots: Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1248-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1248-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-05	2025-02-27

Product code FRC

K163646Class IITerragene 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)