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U.S. Department of Health and Human Services

Class 2 Device Recall BIOTRACE

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 Class 2 Device Recall BIOTRACEsee related information
Date Initiated by FirmJanuary 15, 2025
Date PostedFebruary 27, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1248-2025
Recall Event ID 96176
510(K)NumberK163646 
Product Classification Indicator, biological sterilization process - Product Code FRC
ProductASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Code Information Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.
Recalling Firm/
Manufacturer		 TERRAGENE S.A.
Ruta Nacional N 9, Km 280, Cp 2130
Parque Industrial Micropi
Alvear Argentina
For Additional Information ContactMaximiliano Catalano
341 -837-7243
Manufacturer 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.
FDA Determined
Cause 2		Labeling False and Misleading
ActionThe 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 Commerce914 devices in the U.S.
DistributionUS Nationwide distribution in the states of CA and KY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRC
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