CLASS II Device recall · Reported 20 Jan 2021 · FDA Enforcement Report
Covid-19 Test kit *** An in vitro diagnostic recalled by Visby Medical
Visby Medical is recalling visby medical Covid-19 Test kit *** An in vitro diagnostic for the qualitative detection, distributed nationwide in the US. The recall was initiated on 5 Dec 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0847-2021
- FDA event ID
- 87049
- Recalling firm
- Visby Medical, San Jose, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Dec 2020
- FDA classified
- 12 Jan 2021
- Reported
- 20 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Dec 2020 | Recall initiated by company | |
| 12 Jan 2021 | Classified by FDA | +38 days |
| 20 Jan 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide distribution including in the states of CA, DC, FL, GA, MD, MN, MT, VA, and WA. O.U.S.: None
Nationwide CaliforniaDistrict of ColumbiaFloridaGeorgiaMarylandMinnesotaMontanaVirginiaWashington
Questions about this recall
Is Covid-19 Test kit *** An in vitro diagnostic for the qualitative detection of Sars-CoV-2 recalled?
Yes. Visby Medical recalled Covid-19 Test kit *** An in vitro diagnostic for the qualitative detection of Sars-CoV-2 on 5 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-0847-2021.
Why was it recalled?
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.
Which lots are affected?
Part Number: PS-001442 Lot Numbers: LN20100067 LN20100148 LN20110040 LN20110213 WR20100003 Emergency Use Authorization (EUA202677)
Where was it sold?
U.S. Nationwide distribution including in the states of CA, DC, FL, GA, MD, MN, MT, VA, and WA. O.U.S.: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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