Data / Medical devices / Sweden / Hemocue AB

Hemocue AB: FDA-registered device maker in ANGELHOLM Skane, Sweden, 8 510(k) clearances

Name: Hemocue AB FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hemocue AB is registered with the FDA (registration 3003044483) in ANGELHOLM Skane, Sweden. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 4, 2020. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003044483
Address: Kuvettgatan 1, ANGELHOLM Skane, Sweden, SE-262 71
Owner or operator: HemoCue AB (9099323)
Roles: Manufacturer
First device listed: November 9, 2007
Registered through: 2026
Brand names listed: HemoCue Glucose 201 DM System, HemoCue Glucose 201 System, HemoCue Hb 201 DM System, HemoCue Hb 201 System, HemoCue Hb 301 System, HemoCue Hb 801 System, HemoCue Plasma/Low System, HemoCue WBC System

Devices it lists

Device	Product code	Class	Role	Source
Counter, Cell, Automated (Particle Counter)	GKL	2	Manufacturer	accessdata.fda.gov
Glucose Dehydrogenase, Glucose	LFR	2	Manufacturer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Manufacturer	accessdata.fda.gov
System, Hemoglobin, Automated	GKR	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 4, 2020	K201217	HemoCue Hb 301 System	GKR	Substantially Equivalent	Hemocue AB	accessdata.fda.gov
February 1, 2019	K181751	HemoCue Hb 801 System	GKR	Substantially Equivalent	Hemocue AB	accessdata.fda.gov
October 25, 2007	K071652	HEMOCUE WBC SYSTEM	GKL	Substantially Equivalent	Hemocue AB	accessdata.fda.gov
June 8, 2006	K061047	HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801	GKR	Substantially Equivalent	Hemocue AB	accessdata.fda.gov
June 10, 2004	K041234	HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM	GKR	Substantially Equivalent	Hemocue, Inc.	accessdata.fda.gov
May 20, 2004	K041230	CLINICAL LABORATORY ANALYZING SYSTEM	LFR	Substantially Equivalent	Hemocue, Inc.	accessdata.fda.gov
August 25, 2003	K032203	HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704	GKR	Substantially Equivalent	Hemocue, Inc.	accessdata.fda.gov
April 3, 2002	K020935	HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706	CGA	Substantially Equivalent	Hemocue, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 12, 2025	97025	Class II	Ongoing	The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a p	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	accessdata.fda.gov
July 25, 2013	65920	Class II	Terminated	HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden	HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.	accessdata.fda.gov
July 16, 2013	65918	Class II	Terminated	HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201	HemoCue AB has become aware of a production related problem involving punctured HemoCue Urine Albumin Microcuvettes single pack pouches.	accessdata.fda.gov
July 15, 2013	65854	Class II	Terminated	HemoCue Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantit	During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.	accessdata.fda.gov
November 7, 2012	63825	Class III	Terminated	Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The fi	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.	accessdata.fda.gov

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Updated July 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.