Recall Z-1248-2025 ยท FRC Indicator, Biological Sterilization Process
TERRAGENE S.A.
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
| Date | Feb 27, 2025 (initiated Jan 15, 2025) |
| Status | Open, Classified |
| 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 dev |
| Quantity | 914 devices in the U.S. |
| Distribution | US Nationwide distribution in the states of CA and KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163646 | Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222- Terragene S.A., Nov 2, 2017 |