Wellness

[Mindy D]

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-expands-n...

The company, Universal Meditech, is going out of business and is recalling all of its test kits. There's a variety of types of kits. They were originally sent to distributors that could have sent them out across the country. There are ketone test strips, pregnancy test strips, ovulation test strips, UT I test strips just to name a few of the types.  Please see the FDA page for the most complete information about this recall. 

Below is quoted from the FDA website page for this recall:

• ealthyWiser 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 our expense (please contact us for the courier account information).

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-M5-2202-02
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