Some of the Universal Meditech Recalled Test Kits.
On May 22, 2023, Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is due to the reasons that:
Consumers who still have unused tests manufactured by Universal Meditech Inc. (please refer to product identifications below) should stop using the device immediately and:
Recalled products were manufactured and distributed from March 2021 to November 2022.
To date, there has not been any reported injury due to the use of any of the products.
Universal Meditech Inc. is notifying its distributors by email and is arranging for the return of all recalled products.
Universal Meditech Inc. has distributed the products to distributors in California, New York, New Jersey, and Florida, and these products may have been further sold to end consumers national-wide across the United States.
Source: FDA
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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 (Old address = ml@linlawgroup.com.) recall@universal-meditech.com
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
*Note: This product is exempted from 510(k), so that it was legally distributed without it having been reviewed or cleared by the FDA. However, an “FDA Cleared” verbiage was printed on the product labeling, which was misleading and violative.
**Note: FDA has mandated these products to bear a Unique Device Identifier (UDI) on their labeling, but Universal Meditech has failed to comply with this requirement.
***Note: This is the brand name that appears on the outer box of the product. The name that appears on the pouches inside the box is PrestiBio LH TEST STRIP Urine Test Strip.
****Note: This is the brand name that appears on the outer box of the product. The name that appears on the pouches inside the box is PrestiBio HCG TEST STRIP Urine Test Strip.
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.
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.