Devices

Device Recall HemoCue Glucose 201 Microcuvettes,

Model / Serial
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 Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
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 Description
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.
Manufacturer
Hemo Cue, Inc.
1 Event
- Recall of Device Recall HemoCue Glucose 201 Microcuvettes,

Manufacturer

Hemo Cue, Inc.

Manufacturer Address
Hemo Cue, Inc., 11331 Valley View St, Cypress CA 90630-5366
Source
USFDA

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