Z-1277-2022 Class I Ongoing
FDA device recall Z-1277-2022 was initiated by American Contract Systems, Inc. on May 2, 2022 and is designated Class I. Reason for recall: Affected products were assembled off-site by individuals who may not have been properly trained. The recall status is ongoing. Affected quantity: 274,400 kits total.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 13, 2022
- Initiation Date
- May 2, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 274,400 kits total
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.
Distribution Pattern
US distribution in the state of Minnesota.
Code Information
UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1277-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026