CLASS II ONGOING Device recall · Reported 7 Feb 2024 · FDA Enforcement Report

Bionova PCD (PCD222-C) recalled by Terragene

Terragene is recalling Bionova PCD (PCD222-C), distributed nationwide in the US. The recall was initiated on 7 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Number: Terragene Bionova PCD (PCD222-C) UDI-DI code: 07798164676027 Serial Numbers: F20002 F20021 F20046

Quantity recalled80 stripes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0837-2024
FDA event ID: 93625
Recalling firm: Terragene, Alvear
Classification: Class II
Status: Ongoing
Recall initiated: 7 Dec 2023
FDA classified: 26 Jan 2024
Reported: 7 Feb 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

7 Dec 2023	Recall initiated by company
26 Jan 2024	Classified by FDA	+50 days
7 Feb 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

Product as listed by the FDA

Terragene Bionova PCD (PCD222-C)

Where it was distributed

U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.

Nationwide Georgia Indiana Michigan Montana New York Pennsylvania Texas Virginia

Questions about this recall

Why was it recalled?

Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

Which lots are affected?

Product Number: Terragene Bionova PCD (PCD222-C) UDI-DI code: 07798164676027 Serial Numbers: F20002 F20021 F20046

Where was it sold?

U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 93625

Reported	Class	Recall	Company	Reason	Where
7 Feb 2024	CLASS II	Integron IT26-C Terragene Integron IT26-C recalled	Terragene	Other	Nationwide

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