VISBY MEDICAL INC: Medical Device Recall in 2021 - (Recall #: Z-0847-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization.

Product Classification:

Class II

Date Initiated: December 5, 2020

Date Posted: January 20, 2021

Recall Number: Z-0847-2021

Event ID: 87049

Reason for Recall:

Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration date on the test kits.

Status: Terminated

Product Quantity: Total = 282 kits

Code Information:

Part Number: PS-001442 Lot Numbers: LN20100067 LN20100148 LN20110040 LN20110213 WR20100003 Emergency Use Authorization (EUA202677)

Distribution Pattern:

U.S. Nationwide distribution including in the states of CA, DC, FL, GA, MD, MN, MT, VA, and WA. O.U.S.: None

Voluntary or Mandated:

Voluntary: Firm initiated