Recall Z-1277-2022— American Contract Systems, Inc.
Class I · Ongoing
Class I FDA medical device recall by American Contract Systems, Inc., initiated 2022-05-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A. Reason: Affected products were assembled off-site by individuals who may not have been properly trained..
- Recalling firm
- American Contract Systems, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-05-02
- Firm location
- Kansas City, MO, United States
Product description
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Reason for recall
Affected products were assembled off-site by individuals who may not have been properly trained.
Data sourced from openFDA. This site is unofficial and independent of the FDA.