The Recall Desk

Manufacturer

Universal Meditech Inc.

28 recalls in our database name Universal Meditech Inc. as the manufacturing or recalling firm.

What the numbers show

Total
28
Critical
0
Severe
1
Most recent
2023-11-01

Of the 28 recalls from Universal Meditech Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–28 of 28

  • ModerateFDA (Devices)·Z-0053-2024·2023-11-01

    Multiple Diagnostic Test Strips Recalled for Unverified Quality Standards

    Universal Meditech Inc. is recalling multiple diagnostic test strips (breastmilk alcohol, SARS-CoV-2 antibody, and ketone tests) distributed in the U.S. and Taiwan because the company is closing and cannot provide documentation of manufacturing compliance or post-market surveillance records.

    Product
    PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0063-2024·2023-11-01

    Pregnancy test strips recalled for lack of FDA authorization and quality documentation

    Universal Meditech Inc. recalled DiagnosUS hCG pregnancy test strips because the company distributed them without FDA marketing authorization and cannot provide manufacturing compliance documentation. The firm is ceasing operations.

    Product
    DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0929-2023·2023-02-08

    SARS-CoV-2 Antigen Rapid Test Kits Recalled for Lack of FDA Authorization

    Universal Meditech Inc. is recalling approximately 56,300 SARS-CoV-2 Antigen Rapid Test Kits distributed without FDA approval, clearance, or Emergency Use Authorization. Products were distributed nationwide in California and Texas.

    Product
    Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TES
    Category
    Medical Device
    Distribution
    Distributed nationwide