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

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 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.

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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)

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:

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

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.