Hemocue, Inc.
Country not established FDA
Hemocue, Inc. is a medical device manufacturer, with 46 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II and I) and 8 FDA recalls as of 13 Nov 2026.
- Devices
- 46
- Registrations
- FDA
- FDA recalls
- 81 ongoing
Registry facts
- Registries
- FDA GUDID 31
- FDA 510(k) 15
- EUDAMED 2
- Device classes
- FDA Class II 42
- FDA Class I 4
- FDA recalls
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
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.
Catalogue
Search and filter all 46 devicesFDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
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.
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.
Full distribution text
- 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.
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- 15 Jul 2013 Z-2190-2013 Class II Terminated During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
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- 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.
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.
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.
Full distribution text
- 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.
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.
Full distribution text
- 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.
Full distribution text
- 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.
FDA establishments
- Hemocue Ab ANGELHOLM Skane · SE FEI 3003044483
Frequently asked questions
How many devices does Hemocue, Inc. have in the registry?
The registry currently lists 46 devices for Hemocue, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hemocue, Inc.'s devices?
Among its 46 most recently registered devices, Hemocue, Inc. has devices listed in EUDAMED (2 devices), FDA 510(k) (15 devices) and FDA GUDID (31 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Hemocue, Inc.'s devices fall under?
Among its 46 most recently registered devices, the classes recorded for Hemocue, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Hemocue, Inc.?
FDA recall records list 8 recalls initiated by Hemocue, Inc., the most recent initiated on 12 May 2025. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Hemocue, Inc. in the registry?
The most recently registered devices listed for Hemocue, Inc. include HemoCue® Hb 201 DM Analyzer 121146, HemoCue® Plasma/Low Hb Photometer 120314, HemoCue® Hb 201 Microcuvettes 111732 and HemoCue® Glucose 201 Analyzer 120707.
Which FDA establishments are linked to Hemocue, Inc.?
1 FDA establishment is linked to Hemocue, Inc. in the registry; they are listed on the company page.