Recall Z-0837-2024— TERRAGENE S.A.
Class II · Ongoing
Class II FDA medical device recall by TERRAGENE S.A., initiated 2023-12-07. It names one FDA 510(k) clearance: K163646. Product: Terragene Bionova PCD (PCD222-C). Reason: Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products..
- Recalling firm
- TERRAGENE S.A.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-07
- Firm location
- Alvear, Argentina
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Terragene Bionova PCD (PCD222-C)
Reason for recall
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Data sourced from openFDA. This site is unofficial and independent of the FDA.