EXPANDED – Universal Meditech Recalls all Products Made Between March 2021 and November 2022


Medical Recalls

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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:

  • The company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities of these distributed products.
  • Four 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.


Consumers who still have unused tests manufactured by Universal Meditech Inc. (please refer to product identifications below) should stop using the device immediately and:

  • discard any remaining stock in the trash
  • or ship back to Universal Meditech at the company's expense (please contact them for the courier account information).


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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Consumer Contact: -

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

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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-M5-2202-02
hCG-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-2209-01
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

*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.


Report a Problem With This Product

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.

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You Are Leaving Us

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.

You Are Leaving Us

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.

You Are Leaving Us

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.

You Are Leaving Us

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.

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