Z-0837-2024Class II

Terragene Bionova PCD (PCD222-C)

Name: Z-0837-2024 Terragene Bionova PCD (PCD222-C)
Creator: Terragene S.a.
Published: 2023-12-07
License: https://open.fda.gov/license/

Terragene LLC / initiated 2023-12-07 / Open, Classified / root cause: labeling and UDI

FDA source

TERRAGENE S.A. began a recall of Terragene Bionova PCD (PCD222-C) on 2023-12-07. FDA classified it as Class II and gives the reason as "Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0837-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-07
Posted: 2024-01-26
Recalling firm: Terragene LLC
Product: Terragene Bionova PCD (PCD222-C)
Product code: FRC Indicator, Biological Sterilization Process
Reason for recall: Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Root cause tag: labeling and UDI
FDA 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 [email protected] or www.terragene.com , or +1-844-837-7243 Monday thru Friday 6:00 AM to 3:00 PM, Eastern Time.
Quantity in commerce: 80 stripes
Distribution: U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
Product codes and lots: Product Number: Terragene Bionova PCD (PCD222-C) UDI-DI code: 07798164676027 Serial Numbers: F20002 F20021 F20046

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0837-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0836-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0837-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26

Product code FRC

K163646Class IITerragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorTerragene S.A. / cleared 2017-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)