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Safety Report: Universal Meditech Inc. Test kits update- recalled due to Product Safety/Defect, USA

8 months ago •source fda.gov

Recall notice

Universal Meditech Inc. Test kits update- recalled due to Product Safety/Defect photo #1

United States

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: The company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities of these distributed products. 4 of the products (PrestiBio Breastmilk Alcohol Test Strip, PrestiBio™ Ketone Test Strips, HealthyWiser KetoFast™ Ketone Test Strips and DiagnosUS® SARS-CoV-2 Antibody (IgG/IgM) Test) have 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**
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
17 DiagnosUS® One Step LH Ovulation Test (Strip) None** LH-S-2204-01-S LH-S-2111-01-S
18 DiagnosUS® SARS-CoV-2 Antibody (IgG/IgM) Test None** COV-UL-2208-01
19 DiagnosUS® One Step FSH Menopausal Test (Strip None** FSH-S-2106-01 FSH-S-2108-01 FSH -S-2111-01-S
20 Lem Fertility hCG Pregnancy Urine Test None** hCG -S-2112-02
21 Lem Fertility LH Ovulation Test (Strip) None** LH-S-2112-01
22 DiagnosUS® hCG Pregnancy Urine Test Strip Format None** hCG-S-2101-01 hCG-S-2111-01-S hCG-S-2112-01
23 DiagnosUS® hCG Pregnancy Urine Test Cassette Format None** hCG-M5-2103-01 hCG-M5-2106-02 hCG- M5-2109-01 hCG- M5-2203-01
24 DiagnosUS® hCG Pregnancy Serum/Urine Test Cassette Format None** hCG-M5-2106-03
25 DiagnosUS® Pregnancy Test Midstream 710928980000 hCG-M11-2103-01 hCG-M11-2105-01
26 DiagnosUS® Ovulation Predictor Midstream 697691538914 LH-M11-2101-01 LH-M11-2105-01 LH-M11-2106-01 LH-M11-2107-01

Consumers who still have 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 at our expense.

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: Product Safety/Defect
FDA Recall date: September 22, 2023

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

#medicaldevices #us

321

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