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BIOTRACE recallZ-1248-2025 · Terragene S.A. · initiated Jan 15, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Terragene S.A. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.

FDA root cause category: Labeling False and Misleading

What the company is doing

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.

Recall details

Recall number
Z-1248-2025
Status
Open, Classified
Initiated by the company
Jan 15, 2025
Posted by the FDA
Feb 27, 2025
Recalling firm
Terragene S.A.
Quantity
914 devices in the U.S.
Product code
FRC
FDA submissions
K163646
Distribution
US Nationwide distribution in the states of CA and KY.

Product description

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

Code information (models, lots, serial numbers)

Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K163646 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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