SML Distribution, LLC: Medical Device Recall in 2022 - (Recall #: Z-0944-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

Product Classification:

Class I

Date Initiated: March 4, 2022

Date Posted: May 11, 2022

Recall Number: Z-0944-2022

Event ID: 89975

Reason for Recall:

The product was distributed without FDA authorization or clearance for marketing and distribution in the US.

Status: Ongoing

Product Quantity: 209,450 units

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.

Voluntary or Mandated:

Voluntary: Firm initiated