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Terminated

HemoCue Glucose 201 Microcuvettes, Article Number:110705*,110706,110715**,110716**,110717**,110718**, 110719** " No affected lots of this article have been delivered to customers. Still in stock at distributor HemoCue Inc. "" Article not available in US Quantitative determination of glucose in whole blood, using a specially designed analyzer, the HemoCue Glucose 201 Analyzer. 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. HemoCue Glucose 201 Microcuvettes are for In Vitro Diagnostic use only and are only to be used with the HemoCue Glucose 201 Analyzer. For professional use only.

FDA Recall Z-0824-2012 · Posted 2012-01-20

Recalling FirmHemo Cue, Inc.
Recall StatusTerminated
Product CodeCGA
Date Initiated2011-05-30
Date Terminated2012-03-02
Product Quantity13,620 packages

Reason for Recall

A recall was initiated because Hemocue confirmed that the package insert for Hemocue Glucose 201 Microcuvettes had errors in two sections.

Firm Action

HemoCue sent a Medical Device Correction Notification letter dated June 14, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to passed on the notice to all that need to be aware with their organization or to any organization where the affected lot numbers have been distributed. Customers were instructed to sign the Correction Notification Verification form below and return to HemoCue Inc. Customers received the revised package insert with the notification letter. Customers with any questions regarding the Correction Notification could please call (562) 668-5665.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution--USA (nationwide) and the countries of Czech Republic, Denmark, Slovenia, Norway, Sweden, Switzerland, United Kingdom, Finland, Germany, Netherlands, Poland, Romania, and Tanzania.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020935HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706Hemocue, Inc. · 2002-04-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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