Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

HemoCue¿ Glucose 201 Microcuvettes Recalled by HemoCue AB Due to During a complaint investigation HemoCue AB discovered punctured...

Date: July 15, 2013
Company: HemoCue AB
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact HemoCue AB directly.

Affected Products

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 specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

Quantity: 22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US

Why Was This Recalled?

During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About HemoCue AB

HemoCue AB has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report