FDA Device Recall Z-1044-2022

Woodside Acquisitions Inc. · tyrone, PA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test

Lot / serial / GTIN: All lots

Quantity: 34,240 units

Reason for recall

Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.

Recall record

Recall number: Z-1044-2022
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US distributions to states of: AL and GA.
Recall initiated: 2022-04-09
Classified by FDA Center: 2022-05-12
FDA published: 2022-05-18
Recalling firm: Woodside Acquisitions Inc.
Firm location: tyrone, PA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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