FDA Medical Device Recalls (openFDA)
SML Distribution, LLC: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
- Recall number
- Z-0944-2022
- Recalling firm
- SML Distribution, LLC
- Product
- Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
- Status
- Open, Classified
- Initiated
- 2022-03-04
- Posted
- not on file
- Terminated
- not on file
- Reason
- The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
- Root cause
- No Marketing Application
- Action
- The firm initially contacted affected customers by phone between March 4 and March 12, 2022. On March 21, 2022, the firm followed up with emails to each affected distributor with subject line "IMPORTANT!!! Recall Notice" which included a recall letter attachment. Customers were asked to immediately return all unused product. The firm sent an additional email on March 25, 2022 which instructed customers to not rely on the recalled tests to make medical decisions. As of April 9, 2022, the full recall notice can be found at www.smldistribution.com.
- Quantity
- 209,450 units
- Distribution
- US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.
- Lot, serial or model codes
- All lots: UL-AG-2110-05-Q UL-AG-2111-02-Q UL-AG-2112-01-Q UL-AG-2112-02-Q UL-AG-2201-03-Q
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3022161362
- Firm city
- tyrone
- Firm state
- PA
- 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