Safety Report: Universal Meditech Inc Test kits - recalled due to lacking premarket clearance, risking inaccurate test results, USA

United States

Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is because the company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities of these distributed products, and 3 of the products (PrestiBio Breastmilk Alcohol Test Strip, PrestiBio™ Ketone Test Strips and HealthyWiser KetoFast™ Ketone Test Strips) has been violatively distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA. These products have been distributed to distributors in California, New York, New Jersey, and Florida, and they may have been further sold to end consumers national-wide across the United States. To date, there has not been any reported injury due to the use of any of the products.

Recalled products were manufactured and distributed from March 2021 to November 2022. The following styles/models/UDI have been recalled:

No. Product Name UDI Number Lot Number to be Recalled
1 One Step® Pregnancy Test B512100011 3-H25052-20UMI 3-H07102-20UMI
2 One Step® Ovulation Test* B512200011 3-L12121-20UMI 3-L07102-20UMI
3 HealthyWiser UriTest™ 10 Parameter Reagent Test Strips for Urinalysis None** URS-1-2104-01 URS-1-2102-02 URS-1-2105-01 URS-1-2106-02 URS-1-2110-02
4 HealthyWiser UriTest™ UTI Test Strips None** URS-1-2102-03 URS-1-2106-01 URS-1-2202-01-Q URS-1-2204-01 URS-1-2207-01 URS-1-2209-01
5 HealthyWiser KetoFast™ Ketone Test Strips None** URS-1-2104-02
6 HealthyWiser pH-Aware™ pH Test Strips None** URS-1-2105-01-Q URS-1-2105-02-Q URS-1-2108-01-Q URS-1-2109-01-Q URS-1-2111-01-Q
7 hCG Pregnancy Cassette None** hCG-M5-2101-01 hCG-M5-2104-01 hCG-M5-2106-01 hCG-M5-2107-01 hCG-M5-2108-01 hCG-M5-2110-01 hCG-M5-2202-01 hCG-M5-2202-02hCG-M5- 2202-03 hCG-M5-2203-01 hCG-M5-2204-01 hCG-M5-2204-02 hCG-M5-2204-03 hCG-M5-2206-01 hCG-M5-2206-02 hCG-M5-2207-01 hCG-M5-2210-02
8 Am I Pregnant Pregnancy Midstream Test None** hCG-MHM-2205-01 hCG-MHM-2207-01 hCG-MHM-2207-02 hCG-MHM-2207-03 hCG-MHM-2207-04 hCG-MHM-2208-01 hCG-MHM- 209-01 hCG-MHM-2209-02 hCG-MHM-2209-03 HCG-MHM-2210-01 HCG-MHM-2210-02
9 hCG Pregnancy Strips None** hCG-S-2210-03
10 PrestiBio™ Breastmilk Alcohol Test Strip None** Any Lot Number
11 PrestiBio™ Ovulation Strips*** None** Any Lot Number
12 PrestiBio™ Ovulation and Pregnancy Strips None** Any Lot Number
13 PrestiBio™ Pregnancy Strips**** None** Any Lot Number
14 PrestiBio™ Rapid Detection Pregnancy Test Midstream None** Any Lot Number
15 PrestiBio™ Ketone Test Strips None** Any Lot Number
16 PrestiBio™ Urinalysis Test Strip None** Any Lot Number

Consumers who still have these unused tests manufactured by Universal Meditech Inc. should stop using the device immediately and discard any remaining stock in the trash or ship back to Universal Meditech.

In case you experience harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Universal Meditech Inc.
Brand name: Healthy Wiser and more
Product recalled: Test kits
Reason of the recall: Due to lack of appropriate premarket clearance or approval which potentially could result in inaccurate test results
FDA Recall date: August 31, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-issues-nationwide-recall-all-products-manufactured-between-march-2021-and