The Recall Desk

Manufacturer

Biomeme, Inc.

3 recalls in our database name Biomeme, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2022-01-12

Of the 3 recalls from Biomeme, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–3 of 3

  • ModerateFDA (Devices)·Z-0452-2022·2022-01-12

    Biomeme SARS-CoV-2 Test Instructions Recall: Incorrect Buffer Shelf-Life

    Biomeme, Inc. is recalling instructions for the SARS-CoV-2 Real Time RT-PCR Test because shelf-life guidance for resuspended RPC Buffer is incorrect. Instructions specify one week stability, but the buffer is only stable for two days at room temperature.

    Product
    Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564
    Category
    Medical Device
    Distribution
    16 states
  • LowFDA (Devices)·Z-0940-2021·2021-02-10

    Biomeme PCR Thermocycler Recalled Due to Software Error Preventing Test Completion

    Biomeme, Inc. is recalling 147 Franklin Real-Time PCR Thermocycler systems because a software error causes instrument failure, preventing users from completing 2019-nCoV tests.

    Product
    Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,10000
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0513-2021·2020-12-09

    Biomeme SARS-CoV-2 PCR Test Recalled for False Positive Results

    Biomeme is recalling 105 units of its SARS-CoV-2 Real-Time RT-PCR Test because the software made false positive calls due to assay issues.

    Product
    The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro
    Category
    Medical Device
    Distribution
    Distributed nationwide