Universal Meditech Test Kits Recall: Reason, Affected Products, and All You Need to Know

Universal Meditech Inc. recalls several other test kits produced between March 2021 and November 2022 as it goes out of business (Image via FDA)
Universal Meditech Inc. recalls several other test kits produced between March 2021 and November 2022 (Image via FDA)

Universal Meditech Inc. is extending its May recall to include several other test kits produced between March 2021 and November 2022. The nationwide recall applies to over 26 different test and diagnosis kits sold in and around the United States.

The initial recall was issued in May 2023 and came after the establishment announced that it would be going out of business. Due to this, the company said that it could no longer be able to fulfill the post-sales responsibilities regarding the affected products.

Additionally, at least four products by the company were also found to be in violation of federal laws as they were distributed across the US without a mandatory premarket clearance.

The affected test and diagnosis kits are being recalled as the establishment is dissolving its business (Image via Universal Meditech Inc.)
The affected test and diagnosis kits are being recalled as the establishment is dissolving its business (Image via Universal Meditech Inc.)

The affected products could pose risks of giving false or inaccurate results. This could, in some cases, lead to a delay in diagnosis and treatment of certain conditions and/or diseases. While neither of the recalled products is known to be linked with adverse effects of any sort, consumers nationwide are advised not to use them anymore.


All you need to know about Universal Meditech Test Kits Recall

Universal Meditech is forced to recall over 26 test and diagnosis kits from across the country as the establishment is dissolving its business. The company can no longer handle the after-sales responsibilities related to the affected products as they are shutting down their business.

The establishment is also feared to have distributed select products without the benefit of a premarked clearance, thus having violated federal laws. These products include

  • PrestiBio Breastmilk Alcohol Test Strip
  • PrestiBio™ Ketone Test Strips
  • HealthyWiser KetoFast™ Ketone Test Strips
  • DiagnosUS® SARS-CoV-2 Antibody (IgG/IgM) Test.

As mentioned earlier, the affected products were produced between 'March 2021 to November 2022. Distributed to distributors in the regions of New Jersey, Florida, New York, and California, the affected products may have been sold to customers all across the United States.

The recalled test and diagnosis kits should no longer be used and are best suggested to be thrown away (Image via FDA)
The recalled test and diagnosis kits should no longer be used and are best suggested to be thrown away (Image via FDA)

Consumers are advised to check the table below to find all the information required to check for the recalled Universal Meditech test and diagnosis kits:

NoProduct NameUDI NumberLot Number to be Recalled
1One Step® Pregnancy TestB5121000113-H25052-20UMI
3-H07102-20UMI
2One Step® Ovulation Test*B5122000113-L12121-20UMI
3-L07102-20UMI
3HealthyWiser 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
4HealthyWiser 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
5HealthyWiser KetoFast™ Ketone
Test Strips
None**URS-1-2104-02
6HealthyWiser 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
7hCG Pregnancy CassetteNone**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
8Am 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
9hCG Pregnancy StripsNone**hCG-S-2210-03
10PrestiBio™ Breastmilk Alcohol Test StripNone**
11PrestiBio™ Ovulation Strips***None**Any Lot Number
12PrestiBio™ Ovulation and Pregnancy StripsNone**Any Lot Number
13PrestiBio™ Pregnancy Strips****None**Any Lot Number
14PrestiBio™ Rapid Detection
Pregnancy Test Midstream
None**Any Lot Number
15PrestiBio™ Ketone Test StripsNone**Any Lot Number
16PrestiBio™ Urinalysis Test StripNone**Any Lot Number
17DiagnosUS® One Step LH Ovulation
Test (Strip)
None**LH-S-2204-01-S
LH-S-2111-01-S
18DiagnosUS® SARS-CoV-2 Antibody
(IgG/IgM) Test
None**COV-UL-2208-01
19DiagnosUS® One Step FSH
Menopausal Test (Strip
None**FSH-S-2106-01
FSH-S-2108-01
FSH -S-2111-01-S
20Lem Fertility hCG Pregnancy Urine
Test
None**hCG -S-2112-02
21Lem Fertility LH Ovulation Test
(Strip)
None**LH-S-2112-01
22DiagnosUS® hCG Pregnancy Urine
Test Strip Format
None**hCG-S-2101-01
hCG-S-2111-01-S
hCG-S-2112-01
23DiagnosUS® hCG Pregnancy Urine
Test Cassette Format
None**hCG-M5-2103-01
hCG-M5-2106-02
hCG- M5-2109-01
hCG- M5-2203-01
24DiagnosUS® hCG Pregnancy
Serum/Urine Test Cassette Format
None**hCG-M5-2106-03
25DiagnosUS® Pregnancy Test
Midstream
710928980000hCG-M11-2103-01
hCG-M11-2105-01
26DiagnosUS® Ovulation Predictor
Midstream
697691538914LH-M11-2101-01
LH-M11-2105-01
LH-M11-2106-01
LH-M11-2107-01

Customers who may still have any of the aforementioned products in unused condition are advised not to use them anymore. All test and diagnosis kits affected by this voluntary recall should immediately be thrown away or returned to the establishment. The company is already notifying its distributors about the recall as it begins to arrange to return all affected products.

Individuals looking to send the products back can contact the establishment to receive information about the courier account. They can be reached at +1(702)871-9888. Consumers can also share any concerns about the Universal Meditech Test Kits Recall with the establishment through the same contact details.

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Edited by Madhur Dave
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