Recalls / —

—#194133

Product

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

FDA product code

JSM — Culture Media, Non-Propagating Transport

Device class

Class 1

Medical specialty

Microbiology

Affected lot / code info

UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

On May 2, 2022, the customer was notified by email. The customer was instructed to destroy or discard affected kits.

Recalling firm

Firm

American Contract Systems, Inc.

Address

2610 Ne Industrial Dr, Ste 220, Kansas City, Missouri 64117-2648

Distribution

Distribution pattern

US distribution in the state of Minnesota.

Timeline

Recall initiated

2022-05-02

Posted by FDA

2022-07-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #194133. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.