Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
FDA device recall Z-1277-2022 · posted 2022-07-01 · Open, Classified
Recall details
- Recalling firm
- American Contract Systems, Inc.
- Reason for recall
- Affected products were assembled off-site by individuals who may not have been properly trained.
- Action taken
- On May 2, 2022, the customer was notified by email. The customer was instructed to destroy or discard affected kits.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- JSM
- Quantity affected
- 274,400 kits total
- Distribution
- US distribution in the state of Minnesota.
- Date initiated
- 2022-05-02
- Date posted
- 2022-07-01
- Location
- Kansas City, MO
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