Device recall: One Step Pregnancy Test REF 100-01
Class II FDA enforcement event 92659. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities…
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Universal Meditech Inc. started this device recall on 22 May 2023. The firm address in the FDA record is in Reedley, CA. FDA put the recall in Class II. FDA event 92659 has 27 product records. The first FDA enforcement report date is 1 Nov 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan
Recalling firm
Universal Meditech Inc., Reedley, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
27 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0042-2024 | One Step Pregnancy Test REF 100-01 | 147,000 tests | Class II | Ongoing | 1 Nov 2023 |
| Z-0043-2024 | One Step Ovulation Test REF 200-01 | 100,000 tests | Class II | Ongoing | 1 Nov 2023 |
| Z-0044-2024 | HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10 | 122,500 test strips | Class II | Ongoing | 1 Nov 2023 |
| Z-0045-2024 | HealthyWiser UriTest" UTI Test Strips REF 900-UTI | 5,960 test strips | Class II | Ongoing | 1 Nov 2023 |
| Z-0046-2024 | HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips | 1,500 test strips | Class II | Ongoing | 1 Nov 2023 |
| Z-0047-2024 | HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP | 13,000 test strips | Class II | Ongoing | 1 Nov 2023 |
| Z-0048-2024 | DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 | 4,103 cassettes (25 cassettes/box) | Class II | Ongoing | 1 Nov 2023 |
| Z-0049-2024 | Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 | 45,420 tests | Class II | Ongoing | 1 Nov 2023 |
| Z-0050-2024 | To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10 | 48 boxes (50 strips/box) | Class II | Ongoing | 1 Nov 2023 |
| Z-0051-2024 | PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS | Unknown | Class II | Ongoing | 1 Nov 2023 |
| Z-0052-2024 | PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips | Unknown | Class II | Ongoing | 1 Nov 2023 |
| Z-0053-2024 | PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips | Unknown | Class II | Ongoing | 1 Nov 2023 |
| Z-0054-2024 | PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips | Unknown | Class II | Ongoing | 1 Nov 2023 |
| Z-0055-2024 | PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS | Unknown | Class II | Ongoing | 1 Nov 2023 |
| Z-0056-2024 | PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE | Unknown | Class II | Ongoing | 1 Nov 2023 |
| Z-0057-2024 | PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 | Unknown | Class II | Ongoing | 1 Nov 2023 |
| Z-0058-2024 | DiagnosUS One Step LH Ovulation Test Strip REF 200-07 | 525 devices | Class II | Ongoing | 1 Nov 2023 |
| Z-0059-2024 | DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 | 1,000 test | Class II | Ongoing | 1 Nov 2023 |
| Z-0060-2024 | DiagnosUS One Step FSH Menopausal Test (Strip) REF 210-07 | 2,400 tests | Class II | Ongoing | 1 Nov 2023 |
| Z-0061-2024 | Lem Fertility hCG Pregnancy Urine Test REF 100-12 | 2,500 tests | Class II | Ongoing | 1 Nov 2023 |
| Z-0062-2024 | Lem Fertility LH Ovulation Test (Strip) REF 200-07 | 12,500 tests | Class II | Ongoing | 1 Nov 2023 |
| Z-0063-2024 | DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12 | 5,025 tests | Class II | Ongoing | 1 Nov 2023 |
| Z-0064-2024 | DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 | 25,000 cassettes | Class II | Ongoing | 1 Nov 2023 |
| Z-0065-2024 | DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27 | 1,000 cassettes | Class II | Ongoing | 1 Nov 2023 |
| Z-0066-2024 | DiagnosUS Pregnancy Test Midstream REF 100-17 | 3,304 tests | Class II | Ongoing | 1 Nov 2023 |
| Z-0067-2024 | DiagnosUS Ovulation Predictor Midstream REF 200-17 | 3,600 tests | Class II | Ongoing | 1 Nov 2023 |
| Z-0068-2024 | OMTMO One Step Ovulation (LH) Test Strips REF 200-07 | 40,000 strips | Class II | Ongoing | 1 Nov 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 27Median of the firm: 27
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 Nov 2022 | Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green an Event 91321 | Device | Class I | 1 |
Official channels
- FDA enforcement report Z-0042-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 92659. https://recallregister.com/fda/ii/92659/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan
- What quantity of product is in FDA event 92659?
- The event has 27 product records. The first record gives this quantity:
147,000 tests
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.