Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] T
Summary
The FDA issued a Class II for Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco De by TERRAGENE S.A.. Reason: Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products..
Details
Source
Device Recall
External ID
Z-0836-2024
Action Date
2024-02-07
Status
Ongoing
Category
device
Product Description
Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)
Lot/Code Info: Product Number: IT26-C UDI-DI code: 07798164679622 Lot Numbers: 19033 19038 19039 19040 19057 19105-12 19105-16 B10400-13 B10400-14 B10400-16 B10400-21 B10400-23 19105-23 19105-24 B10519 B10555 B10625 B10627 B10628 B10629 B20040 B20043 B30012 B30013 B30110 B30111 B30112 Product Number: IT26-C with extender UDI-DI code: 07798164678656 Lot Numbers: 19059 B10572 B30068 B30110 Product Number: Terragene Integron (PCD26-C) UDI-DI code: 07798164679370 Lot Numbers: 100320 110320 220620 F10009 F20026 F20079 F20084 Product Number: Benco Dental Chemical Integrator 5726-583 UDI-DI code: 00366975058768 Lot Numbers: 131120-8 131120-1 131120-2 131120-4 131120-7 131120-5 131120-11 131120-3 131120-16 131120-15 131120-12 131120-19 131120-10 131120-6 131120-18 131120-17 131120-14 131120-13 131120-9 B10540 B20039 B20185 B20576 B30010 B30138 Product Number: Tuttnauer (WTL198-0082) UDI-DI code: 07798164677888 Lot Numbers: 120320 170920-3 170920-2 170920-1 170920-8 170920-7 170920-6 170920-5 170920-4 B10331-1 B10331-2 B10331-3 B10539 B20679
Quantity Affected: 36,857 strips
Reason for Recall
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Distribution
U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-07
Company
Alvear
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 221 device recalls issued in the same week, part of 403 device-related FDA actions this month.
TERRAGENE S.A. has 8 FDA actions in our database, including 3 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TERRAGENE S.A.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TERRAGENE S.A. have FDA actions?
TERRAGENE S.A. has 8 FDA actions in our database, including 3 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0836-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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