FDA Medical Device Recalls (openFDA)
American Contract Systems, Inc.: Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
- Recall number
- Z-1277-2022
- Recalling firm
- American Contract Systems, Inc.
- Product
- Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
- Status
- Open, Classified
- Initiated
- 2022-05-02
- Posted
- 2022-07-01
- Terminated
- not on file
- Reason
- Affected products were assembled off-site by individuals who may not have been properly trained.
- Root cause
- Process control
- Action
- On May 2, 2022, the customer was notified by email. The customer was instructed to destroy or discard affected kits.
- Quantity
- 274,400 kits total
- Distribution
- US distribution in the state of Minnesota.
- Lot, serial or model codes
- UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSM
- Firm FEI
- 3003419114
- Firm city
- Kansas City
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28