FDA Medical Device Recalls (openFDA)
TERRAGENE S.A.: ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
- Recall number
- Z-1248-2025
- Recalling firm
- TERRAGENE S.A.
- Product
- ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
- Status
- Open, Classified
- Initiated
- 2025-01-15
- Posted
- 2025-02-27
- Terminated
- not on file
- 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.
- 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
- 914 devices in the U.S.
- Distribution
- US Nationwide distribution in the states of CA and KY.
- Lot, serial or model codes
- Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.
- 510(k) numbers
- ["K163646"]
- PMA numbers
- not on file
- Product code
- FRC
- Firm FEI
- 3013145340
- Firm city
- Alvear
- Firm state
- not on file
- Firm country
- Argentina
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28