Recall Z-2190-2013— HemoCue AB

Name: FDA recall Z-2190-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-15

Class II · Terminated

Class II FDA medical device recall by HemoCue AB, initiated 2013-07-15, terminated 2014-09-02. It names one FDA 510(k) clearance: K020935. 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 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.. Reason: During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches..

Recalling firm: HemoCue AB
Classification: Class II
Status: Terminated
Initiated: 2013-07-15
Terminated: 2014-09-02
Firm location: Angelholm, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K020935 — HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706Hemocue, Inc.·cleared 2002-04-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.