FDA Device Recall Z-1277-2022

American Contract Systems, Inc. · Kansas City, MO

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

Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

Lot / serial / GTIN: UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221

Quantity: 274,400 kits total

Reason for recall

Affected products were assembled off-site by individuals who may not have been properly trained.

Recall record

Recall number: Z-1277-2022
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US distribution in the state of Minnesota.
Recall initiated: 2022-05-02
Classified by FDA Center: 2022-07-01
FDA published: 2022-07-13
Recalling firm: American Contract Systems, Inc.
Firm location: Kansas City, MO

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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