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SARS-Cov-2 Oral Swab Testing
SARS-Cov-2 Oral Swab Testing
This antigen testing is used for in vitro qualitative detection of the antigen of novel coronavirus in human throat swabs. Development clinical trial usage. CE Marked.
The materials provided:
oral swab,
antigen extract buffer,
antigen test cassette/strip,
instructions for use.
559-653-8885 | admin@universal-meditech.com / sales@universal-meditech.com |
COVID-19
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Universal Meditech Inc. Issues Nationwide Recall of Skippack
Medical Lab SARS-CoV-2 Antigen Rapid Test Kit
FOR IMMEDIATE RELEASE: Jan 16, 2023
1320 E Fortune Ave, Suite 102
Fresno, CA 93725
+1(702)871-9888/www.universal-meditech.com
Medical Lab SARS-CoV-2 Antigen Rapid Test Kit
FOR IMMEDIATE RELEASE: Jan 16, 2023
1320 E Fortune Ave, Suite 102
Fresno, CA 93725
+1(702)871-9888/www.universal-meditech.com
On Dec 29, 2022, Universal Meditech Inc. initiated a nationwide recall of 56,300
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits. The product(s) have been
found to have been distributed without appropriate premarket clearance or approval
which potentially could result in inaccurate test results due to lack of performance
evaluation by the FDA.
A recall of the same device has been previously conducted by SML Distribution LLC, for
which the details can be found at the link below:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=193010
Consumers who have Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test
Kits should stop using the device immediately and contact the distributor for product
return.
Kits should stop using the device immediately and contact the distributor for product
return.
Recalled products were manufactured from October 2021 to December 2021 and
distributed in January 2022.
The following styles/models/UDI have been recalled:
- Name of Product: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit
- UDI: None
- Model: Cassette
- Quantity: 56,300
Products were distributed with “Skippack Medical Lab” branded Instructions for Use
leaflet in three different packaging boxes identified below:
- Purple and white box under “Skippack Medical Lab” brand
- Green and white box under “DiagnosUS” brand
- White box without brand name
Universal Meditech Inc. voluntarily recalled the product after becoming aware of the
violative distribution notified by the FDA.
violative distribution notified by the FDA.
To date, there has not been any reported injury.
Universal Meditech Inc. is notifying its distributors and customers by phone and
email and is arranging for return of all recalled products.
Universal Meditech Inc. has distributed the products to distributors in California and
Texas.
Consumers with questions may contact the legal attorney of the company via telephone
at +1(702)871-9888 between the hours of 9AM and 5PM, P.S.T. Consumer may also
contact the legal attorney of the company via e-mail at ml@linlawgroup.com.
Adverse reactions or quality problems experienced with the use of this product may be
reported to the FDA's MedWatch Adverse Event Reporting program either online, by
regular mail or by fax:
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm.
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or
call 1-800-332-1088 to request a reporting form, then complete and return to the
address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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