Z-0847-2021Class II

visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 -

Name: Z-0847-2021 visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 -
Creator: Visby Medical Inc
Published: 2020-12-05
License: https://open.fda.gov/license/

Visby Medical, Inc. / initiated 2020-12-05 / Terminated / root cause: manufacturing process

FDA source

VISBY MEDICAL INC began a recall of 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... on 2020-12-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0847-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-05
Posted: 2021-01-12
Terminated: 2022-01-07
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.
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: Part Number: PS-001442 Lot Numbers: LN20100067 LN20100148 LN20110040 LN20110213 WR20100003 Emergency Use Authorization (EUA202677)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0847-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0847-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-12

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)