CLASS I ONGOING Device recall · Reported 8 Feb 2023 · FDA Enforcement Report
Products are labeled as: Skippack Medical Lab Sars-CoV recalled
Universal Meditech is recalling Products are labeled as: Skippack Medical Lab Sars-CoV-2 Antigen Rapid Test Kit, distributed nationwide in the US. The recall was initiated on 28 Nov 2022 and the FDA has classified it as Class I.
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-0929-2023
- FDA event ID
- 91321
- Recalling firm
- Universal Meditech, Fresno, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 28 Nov 2022
- FDA classified
- 27 Jan 2023
- Reported
- 8 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 28 Nov 2022 | Recall initiated by company | |
| 27 Jan 2023 | Classified by FDA | +60 days |
| 8 Feb 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
Product as listed by the FDA
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING
Where it was distributed
U.S. Nationwide distribution in the states of CA, and TX.
Questions about this recall
Why was it recalled?
Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
Which lots are affected?
Model Number: 550-10 UDI Code: None Lot Numbers: UL-AG-2111-01-Q UL-AG-2111-02-Q UL-AG-2110-05-Q UL-AG-2112-02-Q UL-AG-2110-03-Q UL-AG-2110-04-Q
Where was it sold?
U.S. Nationwide distribution in the states of CA, and TX.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 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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