Recall Z-0837-2024 ยท FRC Indicator, Biological Sterilization Process
TERRAGENE S.A.
Terragene Bionova PCD (PCD222-C)
| Date | Jan 26, 2024 (initiated Dec 7, 2023) |
| Status | Open, Classified |
| Reason | Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products. |
| Root cause | Labeling False and Misleading |
| Action | On 12/07/2023, the firm notified via email its initial importers/distributor a "Voluntary Recall Notification " that contained a "COMMUNICATION TO CUSTOMER VOLUNTARY RECALL OF PRODUCT/URGENT: MEDICAL DEVICE RECALL" Letter informing them of the discrepancies identified in the IFUs of some products that mentions extended cycles that may mislead users to think that these cycles are part of the FDA-cleared indications for use of the product. Initial Importers/Distributors are instructed to send the following information to Terragene: -Quantity in stock -Quantity distributed -Consignees On or ab |
| Quantity | 80 stripes |
| Distribution | U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA. |
| 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 |