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Open, Classified

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

FDA Recall Z-1277-2022 · Posted 2022-07-01

Recalling FirmAmerican Contract Systems, Inc.
Recall StatusOpen, Classified
Product CodeJSM
Date Initiated2022-05-02
Product Quantity274,400 kits total

Reason for Recall

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

Firm Action

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

Root Cause

Process control

Distribution Pattern

US distribution in the state of Minnesota.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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