The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The devices described in this recall notice are the same devices announced in the FDA safety communication Do Not Use Skippack Medical Lab SARS-CoV-2 COVID-19 Tests.
- Product Names: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)
- Product Code: QKP
- Distribution Dates: January 2022
- Devices Recalled in the U.S.: At least 56,300
- Date Initiated by Firm: November 28, 2022
The Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) uses patient samples to detect proteins, called antigens, found on the SARS-CoV-2 virus. The samples are collected in one of two ways:
- Nasal (anterior nares) swab
- Nasopharyngeal swab, which reaches deep inside the nose, reaching the back of the throat or from the middle part of the throat (pharynx)
Reason for Recall
Universal Meditech Inc. is recalling Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests (Colloidal Gold) because these tests were distributed to U.S. customers without authorization, clearance or approval from the FDA. Neither Universal Meditech Inc. nor SML Distribution LLC, has provided the FDA with adequate data to show that the test's performance is accurate. This means there is a risk of potential false negative, false positive, or misinterpretation of results.
Use of the affected product may cause serious adverse health consequences or death.
Universal Meditech Inc. has received no complaints or reports of injuries, deaths, or adverse events.
Who May be Affected
- People who were tested for SARS-CoV-2 using the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold).
- Health care providers and other organizations who used the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold).
What to Do
On December 29, 2022, Universal Meditech Inc. sent a notification letter to consignees requesting them to take the following actions:
- Immediately stop using these tests
- Destroy remaining tests and provide evidence of their disposal or return remaining tests to Universal Meditech Inc.
The FDA's Safety Communication offered recommendations for other affected parties including:
- Test users and caregivers: Talk to your health care provider if you were tested with the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) and you have concerns about your test results.
- Health care personnel: If your patient was tested with the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) in the last 2 weeks and you suspect an inaccurate result, consider retesting your patients using an FDA authorized SARS-CoV-2 diagnostic test. If testing was performed more than two weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
Customers with questions about this recall can call the legal attorney for Universal Meditech Inc. at (702) 871-9888 between 9:00 AM and 5:00 PM PST, or email firstname.lastname@example.org.
- Medical Device Recall Database entry
- Related recall: SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA
- Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices, including suspected false results or injuries from self-swabbed nasopharyngeal or oropharyngeal samples, to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.