The Recall Desk

Manufacturer

HemoCue AB

5 recalls in our database name HemoCue AB as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2025-07-09

Of the 5 recalls from HemoCue AB 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.

1–5 of 5

  • ModerateFDA (Devices)·Z-2070-2025·2025-07-09

    HemoCue glucose microcuvettes experienced transit time outside of specified limits

    Four boxes of HemoCue Glucose 201 Microcuvettes are being recalled because transit time fell outside limits, so stability through the microcuvette lifetime can no longer be guaranteed.

    Product
    The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0086-2014·2013-11-06

    HemoCue Urine Albumin Microcuvettes Recalled for Punctured Packaging

    HemoCue AB is recalling Urine Albumin Microcuvettes due to a production issue causing punctured single-pack pouches.

    Product
    HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0101-2014·2013-11-06

    HemoCue Hb 201 Microcuvettes Recalled for Punctured Packaging

    HemoCue AB is recalling HemoCue Hb 201 Microcuvettes due to a production-related issue causing punctured single-pack pouches.

    Product
    HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2190-2013·2013-09-18

    HemoCue Glucose 201 Microcuvettes Recalled for Punctured Packaging

    HemoCue AB is recalling HemoCue Glucose 201 Microcuvettes because some single-pack pouches were found to be punctured during a complaint investigation.

    Product
    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0619-2013·2013-01-09

    HemoCue Urine Analyzer Recall for Missing Documentation

    HemoCue AB is recalling 48 urine analyzers because they were shipped with the wrong Quick Reference Guide and a missing warranty statement.

    Product
    Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents
    Category
    Medical Device
    Distribution
    17 states