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Hemocue, Inc.

US Last updated 23 May 2026

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Devices
46
Registries
GUDIDEUDAMEDFDA 510(k)FDA
FDA recalls
81 ongoing

Catalogue46

FDA recalls8

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2025

    • 12 May 2025 Z-2070-2025 Class II Ongoing Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.via FDA establishment HEMOCUE AB

  • 2013

    • 25 Jul 2013 Z-0101-2014 Class II Terminated HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.via FDA establishment HEMOCUE AB
    • 16 Jul 2013 Z-0086-2014 Class II Terminated HemoCue AB has become aware of a production related problem involving punctured HemoCue Urine Albumin Microcuvettes single pack pouches.via FDA establishment HEMOCUE AB
    • 15 Jul 2013 Z-2190-2013 Class II Terminated During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.via FDA establishment HEMOCUE AB

  • 2012

    • 7 Nov 2012 Z-0619-2013 Class III Terminated Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the analyzer package.via FDA establishment HEMOCUE AB

  • 2011

    • 30 May 2011 Z-0824-2012 Unclassified (pre-2012) Terminated A recall was initiated because Hemocue confirmed that the package insert for Hemocue Glucose 201 Microcuvettes had errors in two sections.via FDA establishment HEMOCUE AB

  • 2010

    • 7 Oct 2010 Z-1848-2011 Unclassified (pre-2012) Terminated Incorrect configurations settings in software. As a result, certain error codes do not trigger appropriately. These error codes are: E01, E02 and E05 which are all related to the optronic performance of the analyzer. Possible incorrect results.via FDA establishment HEMOCUE AB
    • 7 Oct 2010 Z-1849-2011 Unclassified (pre-2012) Terminated Incorrect configurations settings in software. As a result, certain error codes do not trigger appropriately. These error codes are: E01, E02 and E05 which are all related to the optronic performance of the analyzer. Possible incorrect results.via FDA establishment HEMOCUE AB

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Hemocue Ab ANGELHOLM Skane · SE FEI 3003044483

What Hemocue, Inc. makes

Hemocue, Inc. manufactures in vitro diagnostic (IVD) devices for point-of-care testing, including haemoglobin analysers, glucose monitoring systems, haematological cell analysers, and urine analysers. Their products include microcuvette-based analysers for measuring haemoglobin levels, glucose concentrations, white blood cell counts, and albumin in urine, designed for rapid, portable clinical use.

The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II, and are listed under the 510(k) and UDI programs. These products are authorised for use in the United States, where the manufacturer is based.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Hemocue, Inc. manufacture?

Hemocue, Inc. specializes in in vitro diagnostic (IVD) devices designed for point-of-care use. Their portfolio includes haemoglobin analysers, glucose monitoring systems, haematological cell analysers, and urine analysers. These devices are typically compact, microcuvette-based systems for quick and portable clinical testing, such as measuring haemoglobin levels, glucose concentrations, white blood cell counts, and urine albumin.

Where is Hemocue, Inc. based, and where are their devices authorised for use?

Hemocue, Inc. is based in the United States. Their devices are authorised for use in the US, where they are regulated under FDA guidelines. The company’s products are designed to meet regulatory requirements in this market, ensuring compliance with local standards for in vitro diagnostics.

Which regulatory registries or programs list Hemocue, Inc.’s devices?

Hemocue, Inc.’s devices are listed under the FDA’s 510(k) premarket notification program and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with US regulatory standards for medical devices, particularly for in vitro diagnostics like haemoglobin analysers, glucose monitors, and urine analysers.

How are Hemocue, Inc.’s devices classified under FDA regulations?

Hemocue, Inc.’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact, such as the type of diagnostic testing performed.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US