HemoCue Glucose 201 Microcuvettes recallZ-0824-2012 · Hemo Cue, Inc. · initiated May 30, 2011
Terminated All recalls posted in January 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hemo Cue, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A recall was initiated because Hemocue confirmed that the package insert for Hemocue Glucose 201 Microcuvettes had errors in two sections.
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-0824-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 30, 2011
- Posted by the FDA
- Jan 20, 2012
- Recalling firm
- Hemo Cue, Inc.
- Quantity
- 13,620 packages
- Product code
- CGA
- FDA submissions
- K020935
- 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.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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.
Other devices under the same FDA submission
1 device cleared under K020935 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- HemoCue® Glucose 201 Microcuvettes 110706Hemocue AB · Glucose Oxidase, Glucose2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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