FDA Medical Device Recalls (openFDA)
TERRAGENE S.A.: Terragene Bionova PCD (PCD222-C)
- Recall number
- Z-0837-2024
- Recalling firm
- TERRAGENE S.A.
- Product
- Terragene Bionova PCD (PCD222-C)
- Status
- Open, Classified
- Initiated
- 2023-12-07
- Posted
- 2024-01-26
- Terminated
- not on file
- 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 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.
- Quantity
- 80 stripes
- Distribution
- U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
- Lot, serial or model codes
- Product Number: Terragene Bionova PCD (PCD222-C) UDI-DI code: 07798164676027 Serial Numbers: F20002 F20021 F20046
- 510(k) numbers
- ["K163646"]
- PMA numbers
- not on file
- Product code
- FRC
- Firm FEI
- 3013145340
- Firm city
- Alvear
- Firm state
- not on file
- Firm country
- Argentina
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28