The Recall Desk

Manufacturer

Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc

3 recalls in our database name Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2025-11-26

Of the 3 recalls from Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc 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

  • LowFDA (Devices)·Z-0538-2026·2025-11-26

    Fecal occult blood controls recalled over a wrong expiration date printed

    Polymedco is recalling 403 units of OC-Auto FOBT-CHEK Negative Controls because the kit box and vial labels state an expiration date of 2026-01-16 instead of 2027-01-17.

    Product
    OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-3186-2018·2018-09-26

    Polymedco PATHFAST NTproBNP Cartridges Recalled for Measurement Bias

    Polymedco is recalling 272 PATHFAST NTproBNP cartridges due to a manufacturing defect that may cause measurement values to be 12% to 20% higher than actual.

    Product
    PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3185-2018·2018-09-26

    Polymedco PATHFAST Myoglobin II Cartridges Recalled for Leakage

    Polymedco is recalling 272 PATHFAST Myoglobin II reagent cartridges due to a pinhole defect that may cause measurement bias.

    Product
    PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized
    Category
    Medical Device
    Distribution
    8 states