VISBY MEDICAL INC: 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.

Recall number

Z-0847-2021

Recalling firm

VISBY MEDICAL INC

Product

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.

Status

Terminated

Initiated

2020-12-05

Posted

not on file

Terminated

2022-01-07

Reason

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.

Root cause

Process control

Action

On or about 12/07/2020, the firm contacted via telephone its customers and sent an "URGENT *** Recall and Field Corrective Action" Notification Letter via overnight courier informing them of the two issues pertaining to 5 specific lots of their test kits. The issues are: 1) Expiration Date: Visby COVID-19 Test kits lots LN20100067, LN20100148, LN20110040, have an expiration date on the outer kit boxes that matches the expiration date of the Visby COVID-19 devices contained in the foil pouch test kits. However, the outer kit boxes also contains Visby Dilution Kits with a shorter expiration date. The expiration dates of the affected test kits, Visby COVID-19 devices and Visby Dilution Kits are listed in the following table. While the Visby Dilution Kit packaging is labeled with the correct expiration date, the test kit labeling extends beyond the expiration date of the buffer within the Dilution Kit. The buffer should not be used beyond the expiration date on the Visby Dilution Kit label. 2) CLIA Waiver labeling: The outer kit boxes of all Visby COVID-19 Test kits shipped prior to December 4, 2020, were incorrectly labeled as CLIA waived. The Visby Medical COVID-19 test authorization is limited to use in CLIA moderate and high complexity laboratories. The image below reflects the incorrect labeling. The package insert and other labeling included with the Visby test kit correctly identify these test kits as for use in CLIA moderate and high complexity laboratories. The health risks associated with the two issues: A. Expiration Date: If any patients were tested after the buffer expiration date, there is a potential increased risk of false negative test results. Tests performed prior to the expiration date of the Visby Dilution Buffer are valid and unaffected by this issue. B. CLIA Waiver labeling: There is no impact to patient results related to the incorrect CLIA Waiver labeling. Customer s are instructed to: A. Expiration Date: For Device Lots affected by

Quantity

Total = 282 kits

Distribution

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

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

QJR

Firm FEI

3016608638

Firm city

San Jose

Firm state

CA

Firm country

not on file

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

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