Terragene Bionova PCD (PCD222-C)
FDA device recall Z-0837-2024 · posted 2024-01-26 · Open, Classified
Recall details
- Recalling firm
- TERRAGENE S.A.
- Reason for recall
- Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
- Action taken
- 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 about 12/22/2023, the firm initiated distribution, via email, an "URGENT: MEDICAL DEVICE RECALL" Letter to customers (identified by their Initial Imports/Distributors) informing them of the Recall issue (discrepancy identified in the IFU) provide an updated IFU (version 4) correcting the issue. Customers are instructed to print the updated IFU and attach it to their remaining inventory, and to discard the older IFU versions (version 1 thru 3). For questions or concerns, contact customer.service@terragene.com or www.terragene.com , or +1-844-837-7243 Monday thru Friday 6:00 AM to 3:00 PM, Eastern Time.
- Root cause
- Labeling False and Misleading
- Status
- Open, Classified
- Product code
- FRC
- Quantity affected
- 80 stripes
- Distribution
- U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
- Date initiated
- 2023-12-07
- Date posted
- 2024-01-26
- Location
- Alvear, Argentina
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