Z-0824-2012

HemoCue Glucose 201 Microcuvettes, Article Number:110705*,110706,110715,110716,110717,110718...

Name: Z-0824-2012 HemoCue Glucose 201 Microcuvettes, Article Number:110705*,110706,110715**,110716**,110717**,110718**...
Creator: Hemo Cue, Inc.
Published: 2011-05-30
License: https://open.fda.gov/license/

Hemo Cue, Inc. / initiated 2011-05-30 / Terminated / root cause: packaging

FDA source

Hemo Cue, Inc. began a recall of HemoCue Glucose 201 Microcuvettes, Article Number:110705*,110706,110715**,110716**,110717**,110718**, 110719** " No affected lots of this article have been... on 2011-05-30. The reason FDA records is "A recall was initiated because Hemocue confirmed that the package insert for Hemocue Glucose 201 Microcuvettes had errors in two sections". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0824-2012
Status: Terminated
Initiated: 2011-05-30
Posted: 2012-01-20
Terminated: 2012-03-02
Recalling firm: Hemo Cue, Inc.
Product: 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.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: A recall was initiated because Hemocue confirmed that the package insert for Hemocue Glucose 201 Microcuvettes had errors in two sections.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 13,620 packages
Distribution: Worldwide Distribution--USA (nationwide) and the countries of Czech Republic, Denmark, Slovenia, Norway, Sweden, Switzerland, United Kingdom, Finland, Germany, Netherlands, Poland, Romania, and Tanzania.
Product codes and lots: Lot/batch Number: US: 1011383*, 1102471 *,1102474*,1102487*,1103200*, 1103201**,1103236*,1103213*,1103216*,1103224*, 1103225*,1103226*,1103238*,1103243**,1103246*, 1103250*,1103496*,1103498*,1104272**,1104273**, 1104288**,1104289**,1104548**,1104549**,1104550**, 1104555**,1104556**,1104558**,1104559**,1103212*, 1103240*,1104557** * lots have been shipped to customers ** lots are in stock at distributor HemoCue Inc. Not in US: 1104282, 1105306, 1104530, 1103242, 1103241, 1103244,1103247,1104255,1104258,1103248,1103234, 1104260,1104267,1104274,1104270,1102467,1104277, 1104531,1104532,1104533,1104534,1104535,1103227, 1103228,1103232,1103230,1103233,1104254,1104256, 1103249,1104254,1103245,1104263,1104274,1104286, 1104275,1104283. The lots that are not for the US market are not affected by the labeling infonnation regarding lithium heparin.

Product code CGA

K020935Class IIHemocue Glucose 201 System, Article Number 120706Hemocue, Inc. / cleared 2002-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)