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), may also be called Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit, Lateral Flow COVID 19 Rapid Antigen Test, SKIPPACK COVID-19 Antigen Home Test
- Product Codes: See Recall Database Entry
- Distribution Dates: January 21, 2022 to February 11, 2022
- Devices Recalled in the U.S.: Up to 209,450
- Date Initiated by Firm: March 4, 2022
The Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) uses a nasal swab sample to detect proteins, called antigens, found on the SARS-CoV-2 virus.
Reason for Recall
SML Distribution LLC is recalling these tests because these tests were distributed to U.S. customers without authorization, clearance or approval from the FDA. In addition, SML Distribution LLC did not provide the FDA with adequate validation 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.
If you use the affected product, this may cause serious adverse health consequences or death.
SML Distribution 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 March 20, 2022, SML Distribution LLC sent a Medical Device Recall letter to customers, distributors, and other U.S. consignees requesting them to take the following actions:
- Immediately stop using these tests.
- If the tests were distributed to third parties, perform a recall from all purchasers.
- Return all COVID-19 tests distributed by SML Distribution LLC to SML Distribution LLC.
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 should contact SML Distribution LLC by e-mailing firstname.lastname@example.org or calling 888-209-4406.
- Medical Device Recall Database Entry
- 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.