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Honored Contributor
Posts: 13,510
Registered: ‎05-23-2010

Recall of a variety of medical test kits from Universal Meditech under various brand names

[ Edited ]

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
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