FDA Medical Device Recalls (openFDA)
American Contract Systems, Inc.: COVID Test Kit Nonsterile
- Recall number
- Z-0071-2023
- Recalling firm
- American Contract Systems, Inc.
- Product
- COVID Test Kit Nonsterile
- Status
- Open, Classified
- Initiated
- 2022-08-12
- Posted
- 2022-10-08
- Terminated
- not on file
- Reason
- Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
- Root cause
- No Marketing Application
- Action
- A customer letter dated 08/12/2022 was sent on or around 08/15/2022 to the single impacted consignee. The customer is instructed that the product cannot be used in association with SARS-CoV-2 or COVID-19 testing but instead only for general use of specimen collection. The product is to be relabeled in accordance with the recall communication letter. A Field Action Response Form is to be completed and returned to angela.bunn@owens-minor.com. A second customer letter dated September 8, 2022 was sent on or around the same day to notify the consignee that 2 lots listed in this event cannot be relabeled, as they are subject to destruction from a previous recall event. Those two lots are Product #AHCV18A, lots 980221 and 974221. The consignee is requested to confirm destruction of the lots.
- Quantity
- 39,575 kits
- Distribution
- Distribution to one customer in PA only
- Lot, serial or model codes
- 1) UDI-DI: Product Code: AHCV18A, Lots 980221 (exp. 01/20/2023) and 974221 (exp. 01/25/2023) 2) UDI-DI: Product Code: AHCV18B, Lots 868221 (exp. 05/31/2023), 842221 (exp. 05/31/2023)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSM
- Firm FEI
- 3008908305
- Firm city
- Bloomington
- Firm state
- MN
- 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